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Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia (LEUKA-PICC)

Primary Purpose

Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dressing change
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia focused on measuring Leukemia, Catheters, Dressings

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with a diagnosis of acute myeloblastic leukemia. Patient going on intensive induction chemotherapy (causing a "high risk" situation of severe infection defined as profound neutropenia ( Polymorphonuclear neutrophil count <500/mm3) and lasting (>7 days). Patients who have had a PICCline placed within the last 24 hours or who require a PICCline placement as part of their hospitalization under optimal hygiene and asepsis conditions. Patient housed in a protected environment (flow chamber or Plasmair®). Patient who has given free and informed consent. Patient affiliated or beneficiary of a health insurance plan. Adult patient (≥18 years old). Exclusion Criteria: Patient with PICCline placed during a previous hospitalization. Patient in an exclusion period determined by another study. Patient under court protection, guardianship or curatorship. Patient unable to give consent. Patient for whom it is impossible to give informed information.

Sites / Locations

  • CHU de Montpellier Hôpital St-EloiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Patients receiving normal management with dressings changed once a week according to the SF2H recommendations.

Patients whose dressings are changed every other day.

Outcomes

Primary Outcome Measures

Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.

Secondary Outcome Measures

Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in controls
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Pain or discomfort generated by PICCline dressing changes in the experimental group
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Length of time in hospital in controls
The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home.
Length of time in hospital in the experimental group
The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home.
Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controls
If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination.
Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental group
If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination.

Full Information

First Posted
February 23, 2023
Last Updated
October 12, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05793801
Brief Title
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia
Acronym
LEUKA-PICC
Official Title
Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
June 6, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Peripherally Inserted Central Catheters have been widely used for many years for the administration of chemotherapy to patients with cancer. However, its use entails significant infectious complications and high risks of death.The hypothesis is that increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.
Detailed Description
The PICCline ("Peripherally Inserted Central Catheter") is a central catheter whose brachial insertion is peripheral. It has been widely used for many years for the administration of chemotherapy to patients with cancer. Although its use is growing (2.7 million applications in the USA in 2020), significant infectious complications (especially bacteremia) and even high risks of death are generally associated with it. In December 2013, the French Society of Hospital Hygiene (SF2H) published a guide of "Recommendations for good practices and management of risks associated with PICC" to help professionals in the use of this device. It states that the rate of dressing repair is set at a maximum of 8 days for a sterile semipermeable transparent dressing; however, this recommendation is based on a questionable level of evidence (grade E level of evidence according to the HAS). In the appendix to this guide, the analysis of the scientific literature does not highlight any articles comparing different dressing repair rates. An observational study was conducted at the University Hospital of Nîmes, in order to determine the rate of infection on PICCline in the Hematology Department. In 2019, out of the 90 PICClines applied (dressing changes every 2 days), 12 infections (local and/or systemic) were noted, i.e. 13.3%. In order to know the current practices of the different hematology services in France, a survey was conducted to collect protocols for PICCline dressing changes. A total of 23 haematology departments were contacted, 18 of which responded. The observation was made that, although most departments respected the SF2H recommendation (15 out of 18), others proposed different rhythms of care: (a) in the Hematology department at Nîmes University Hospital, dressings are redone every 48 hours, (b) in Montpellier, the frequency was 2 to 3 times a week, (c) in Grenoble, the use of PICCline was abandoned by the medical team who noted too many infections and thromboses associated with this device, and (d) in Toulouse and Strasbourg, the PICCline was used less and less for these same reasons. Moreover, the SF2H recommendations are addressed in a general way to professionals and valid for all patients; but no study can currently affirm that they are applicable to a fragile population of immunocompromised patients in the context of intensive chemotherapy. Hematology patients have a high risk of febrile neutropenia, of around 80%, and this risk of immunosuppression is a non-negligible point in terms of infection prevention during patient management. In 2019 in France, the Réseau de Prévention des Infections Associées aux Soins launched a campaign to monitor and prevent infections associated with invasive devices. For 3 months, data on the occurrence of infectious episodes were collected in 1001 healthcare facilities. Of the nearly 12,000 bacteremia episodes identified, 25.4% were associated with an intravascular device, 17% of which were PICCline. Moreover, the survey revealed that the highest rates of occurrence were found in the Intensive Care Unit, Oncology and Hematology departments and the prevalence of bacteremia associated with intravascular devices in Hematology represented 39.8%. Hypothesis : increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Leukemia, Catheters, Dressings

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective two-center randomized open-label controlled pilot study in two parallel groups according to PICCline dressing repair: (i) Control group (every 8 days, see SF2H recommendations), (ii) Experimental group (every 2 days).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients receiving normal management with dressings changed once a week according to the SF2H recommendations.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients whose dressings are changed every other day.
Intervention Type
Other
Intervention Name(s)
Dressing change
Intervention Description
The patient circuit corresponds to that of usual care. Not part of usual patient management: The rhythm of PICCline dressing changes, which differed between the two groups. The collection of pain on a visual analog scale at each dressing change.
Primary Outcome Measure Information:
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 1+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 9+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 17+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 25+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 32+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 39+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 46+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 53+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in controls
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 60+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 1+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 3+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 5+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 7+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 9+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 11+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 13+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 15+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 17+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 19+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 21+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 23+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 25+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 27+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 29+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 31+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 33+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 35+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 37+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 39+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 41+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 43+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 45+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 47+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 49+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 51+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 53+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 55+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 57+48 hours
Title
Rate of local and/or systemic occurrence of infection on the PICCline in the experimental group
Description
Occurrence of infection on the PICCline, local and/or systemic, and its time of occurrence according to the definition of the Technical Committee on Nosocomial Infections and Healthcare-Associated Infections (CTINILS) during intensive treatment, from the beginning of induction chemotherapy to the beginning of the first consolidation. Local infection will be recorded from the time of PICCline placement, and systemic infection will be recorded when it occurs.
Time Frame
Day 59+48 hours
Secondary Outcome Measure Information:
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 1
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 9
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 17
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change.
Time Frame
Day 25
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 32
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 39
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 46
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 53
Title
Pain or discomfort generated by PICCline dressing changes in controls
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 60
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 1
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 3
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 5
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 7
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 9
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 11
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 13
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 15
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 17
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 19
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 21
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 23
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 25
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 27
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 29
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 31
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 33
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 35
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 37
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 39
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 41
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 43
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 45
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 47
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 49
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 51
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 53
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 55
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 57
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 59
Title
Pain or discomfort generated by PICCline dressing changes in the experimental group
Description
The patient will be asked to evaluate pain according to a visual analog scale following each dressing change. On this scale, absence of pain = 0 mm and maximum pain imaginable = 100 mm.
Time Frame
Day 61
Title
Length of time in hospital in controls
Description
The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home.
Time Frame
At the end of hospitalization
Title
Length of time in hospital in the experimental group
Description
The duration of time in hospital will be measured from the first day of receiving chemotherapy until transfer towards a healthcare facility for follow-up and rehabilitation or return home.
Time Frame
At the end of hospitalization
Title
Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in controls
Description
If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination.
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Bacterial species isolated after cytobacteriological analysis of samples (blood cultures and PICCline) and sensitivity to antibiotics in the experimental group
Description
If an infection on the PICCline is suspected, the device will be removed and blood cultures will be taken from the PICCLine and the periphery. If the PICCline culture is positive and the blood cultures negative, the infection is local and device-related. If the PICCline culture and peripheral blood cultures are positive, then catheter-related bacteremia is diagnosed. If general signs like fever appear in a patient with a PICCline without local signs of infection, then blood taken from the periphery and blood from the PICCLine will be cultured. If both blood cultures are positive, catheter-related bacteremia is highly probable. If the blood culture bottle taken from the periphery remains negative and there is a strong suspicion of infection related to the PICCline, then new blood cultures from the periphery and from the device will be performed in order to be able to conclude that there is bacteremia/device colonization/contamination.
Time Frame
At the end of the 2-month follow-up, on Day 60
Other Pre-specified Outcome Measures:
Title
Age of patients in the control group
Description
In years
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Age of patients in the experimental group
Description
In years
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Body Mass Index of patients in the control group
Description
Body Mass Index = Weight ÷ (Height)2
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Body Mass Index of patients in the experimental group
Description
Body Mass Index = Weight ÷ (Height)2
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Patients' medical history : control group
Description
The medical history of each patient in the control group will be recorded.
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Patients' medical history : experimental group
Description
The medical history of each patient in the experimental group will be recorded.
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Type of leukemia : control group
Description
The type of leukemia of each patient in the control group will be recorded
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Type of leukemia : experimental group
Description
The type of leukemia of each patient in the experimental group will be recorded
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Treatment start date : control group
Description
The treatment start date of each patient in the control group will be recorded
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Treatment start date : experimental group
Description
The treatment start date of each patient in the experimental group will be recorded
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Date when patients' aplasia started : control group
Description
The date when each patient in the control group started aplasia will be recorded
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Date when patients' aplasia started : experimental group
Description
The date when each patient in the experimental group started aplasia will be recorded
Time Frame
At the inclusion visit (- 48 hours to Day 0)
Title
Date when patients' aplasia ended : control group
Description
The date when each patient in the control group ended their aplasia will be recorded
Time Frame
End of 2-month follow-up
Title
Date when patients' aplasia ended : experimental group
Description
The date when each patient in the experimental group ended their aplasia will be recorded
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Date of hospital discharge : control group
Description
The date when each patient in the control group was discharged from hospital will be recorded.
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Date of hospital discharge : experimental group
Description
The date when each patient in the experimental group was discharged from hospital will be recorded.
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Antibiotic therapy provided : control group
Description
The antibiotic therapy provided to each patient in the control group will be recorded
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Antibiotic therapy provided : experimental group
Description
The antibiotic therapy provided to each patient in the experimental group will be recorded
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Presence of parenteral nutrition : control group
Description
For each patient in the control group. Recorded as YES/NO
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Presence of parenteral nutrition : experimental group
Description
For each patient in the experimental group. Recorded as YES/NO
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Occurrence of thrombosis on the PICCline : control group
Description
For each patient in the control group : YES/NO and date
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Occurrence of thrombosis on the PICCline : experimental group
Description
For each patient in the experimental group : YES/NO and date
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Device related data : control group
Description
Device-related data: number and types of previous central lines, history of infection, type of device, number of lines, type of fixation, type of dressing, device use protocols, description of puncture site appearance, related intercurrent events, identified germs will be recorded for each patient in the control group.
Time Frame
At the end of the 2-month follow-up, on Day 60
Title
Device related data : experimental group
Description
Device-related data: number and types of previous central lines, history of infection, type of device, number of lines, type of fixation, type of dressing, device use protocols, description of puncture site appearance, related intercurrent events, identified germs will be recorded for each patient in the experimental group.
Time Frame
At the end of the 2-month follow-up, on Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with a diagnosis of acute myeloblastic leukemia. Patient going on intensive induction chemotherapy (causing a "high risk" situation of severe infection defined as profound neutropenia ( Polymorphonuclear neutrophil count <500/mm3) and lasting (>7 days). Patients who have had a PICCline placed within the last 24 hours or who require a PICCline placement as part of their hospitalization under optimal hygiene and asepsis conditions. Patient housed in a protected environment (flow chamber or Plasmair®). Patient who has given free and informed consent. Patient affiliated or beneficiary of a health insurance plan. Adult patient (≥18 years old). Exclusion Criteria: Patient with PICCline placed during a previous hospitalization. Patient in an exclusion period determined by another study. Patient under court protection, guardianship or curatorship. Patient unable to give consent. Patient for whom it is impossible to give informed information.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Éric JOURDAN, Dr.
Phone
+334.66.68.32.34
Email
Eric.jourdan@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa MEGZARI
Phone
+33466684236
Email
drc@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie LASSALLE, Mme.
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier Hôpital St-Eloi
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Séverine LOURS, Mme.
Phone
+334 67 33 83 77
Email
s-lours@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Franciane PAUL, Dr.
Phone
+334.67.33.83.55
Email
f-paul@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia

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