Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care (KTESCA)
Primary Purpose
Pressure Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
peripheral venous catheter with compress under the catheter-extension tube junction
peripheral venous catheter without compress under the catheter-extension tube junction
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer focused on measuring pediatrics, pressure ulcer, peripheral venous catheter
Eligibility Criteria
Inclusion Criteria:
- Aged 1 month to 18 years old, according to the criteria of the paediatrics department of the Departmental Hospital la Roche sur Yon .
- Hospitalized in paediatrics ward or consultant in paediatric emergencies with a high probability of being hospitalized in paediatrics ward later.
- With an indication for the insertion of a short peripheral venous catheter
- Written agreement from the holder(s) of parental authority
Exclusion Criteria:
- Children with dermatological affections prior to inclusion and at the puncture site (atopic dermatitis, skin infection, skin wound, chickenpox, epidermolysis bullosa)
- Allergy to fixation devices
- Known immune deficient child
- Refusal of the patient or of the holders of parental authority to participate
- Life-saving emergency care
- Patient already included in the study
- Patient without social security coverage
Sites / Locations
- CHD VendeeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
peripheral venous catheter with compress
peripheral venous catheter without compress
Arm Description
Insertion of a peripheral venous catheter with a compress inserted below the catheter-extension tube junction
Insertion of a peripheral venous catheter without any compress inserted below the catheter-extension tube junction.
Outcomes
Primary Outcome Measures
Pressure ulcer of grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) scale
Appearance of a grade >=1 pressure ulcer on the NPUAP scale at the catheter extension junction. The assessment will be conducted blind by a child care assistant (CDA) from the department.
Secondary Outcome Measures
Pressure ulcer intensity as measured by the NPUAP scale
The NPUAP pressure ulcer rating scale translated in French by the National French Agency for accreditation and assessment of Health (ANAES) will be used. This scale evaluates pressure ulcers according to 4 stages graduated from 1 to 4. Stage 1 being the least severe.
dwell time of peripheral venous catheters between the 2 groups
Will be calculated from the time of catheter placement to the time of catheter removal.
Presence of a nosocomial infection related to the peripheral venous catheter.
Will be defined as a peripheral venous catheter culture > 10^3 Colony Forming Unit/ml, if the peripheral venous catheter is referred in culture on suspicion of infection and in the absence of antibiotic treatment. In the presence of antibiotic treatment, it will be defined by the presence of pus and/or regression of infectious signs within 48 hours after removal of the peripheral venous catheter.
Full Information
NCT ID
NCT04540822
First Posted
August 31, 2020
Last Updated
October 14, 2022
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT04540822
Brief Title
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
Acronym
KTESCA
Official Title
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Peripheral venous catheterisation is a multi-daily practice in a paediatric ward.
In our pediatrics department, nurses have observed for several years now the appearance of pressure sore-like skin lesions at the junction of the peripheral venous catheter with the extension tube. A ward habit has spontaneously developed of applying a compress under this junction. The objective is to minimize physical or emotional aggression as well as pain. Pain that is denied or not identified and not relieved is memorized by the child, which can have consequences on the perception of pain and the subsequent acceptance of care.
To date, through their reading and research, investigators have been able to find articles mentioning the risks of pressure ulcers in children related to medical devices. However, few elements are developed concerning catheter-related pressure ulcers, especially on this specific technique for preventing injuries at the catheter-extension tube junction. Investigators have not found any recommendations on this subject.
Thus, the aim of this study is to compare two peripheral venous catheter fixation devices, with compress and without compress, and to analyse the frequency of pressure ulcer occurrence and the intensity of this lesion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
pediatrics, pressure ulcer, peripheral venous catheter
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The childcare assistant in charge of primary outcome assessment should not having taken care of the child before. In addition, the catheter-extension tube junction, with or without compress,will be secured by placing a crepe bandage. The nurse will call him to assess the primary outcome after the catheter ( and compress and crepe bandage) will have been removed.
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
peripheral venous catheter with compress
Arm Type
Experimental
Arm Description
Insertion of a peripheral venous catheter with a compress inserted below the catheter-extension tube junction
Arm Title
peripheral venous catheter without compress
Arm Type
Active Comparator
Arm Description
Insertion of a peripheral venous catheter without any compress inserted below the catheter-extension tube junction.
Intervention Type
Other
Intervention Name(s)
peripheral venous catheter with compress under the catheter-extension tube junction
Intervention Description
Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. Under the catheter-extension tube junction will be inserted a sterile non-woven compress, cut sterilely (3.5x1.5 cm). The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).
Intervention Type
Other
Intervention Name(s)
peripheral venous catheter without compress under the catheter-extension tube junction
Intervention Description
Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. No compresses will be inserted under the catheter-extension tube junction.The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).
Primary Outcome Measure Information:
Title
Pressure ulcer of grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) scale
Description
Appearance of a grade >=1 pressure ulcer on the NPUAP scale at the catheter extension junction. The assessment will be conducted blind by a child care assistant (CDA) from the department.
Time Frame
at catheter removal
Secondary Outcome Measure Information:
Title
Pressure ulcer intensity as measured by the NPUAP scale
Description
The NPUAP pressure ulcer rating scale translated in French by the National French Agency for accreditation and assessment of Health (ANAES) will be used. This scale evaluates pressure ulcers according to 4 stages graduated from 1 to 4. Stage 1 being the least severe.
Time Frame
at catheter removal
Title
dwell time of peripheral venous catheters between the 2 groups
Description
Will be calculated from the time of catheter placement to the time of catheter removal.
Time Frame
at catheter removal
Title
Presence of a nosocomial infection related to the peripheral venous catheter.
Description
Will be defined as a peripheral venous catheter culture > 10^3 Colony Forming Unit/ml, if the peripheral venous catheter is referred in culture on suspicion of infection and in the absence of antibiotic treatment. In the presence of antibiotic treatment, it will be defined by the presence of pus and/or regression of infectious signs within 48 hours after removal of the peripheral venous catheter.
Time Frame
at catheter removal +48hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 1 month to 18 years old, according to the criteria of the paediatrics department of the Departmental Hospital la Roche sur Yon .
Hospitalized in paediatrics ward or consultant in paediatric emergencies with a high probability of being hospitalized in paediatrics ward later.
With an indication for the insertion of a short peripheral venous catheter
Written agreement from the holder(s) of parental authority
Exclusion Criteria:
Children with dermatological affections prior to inclusion and at the puncture site (atopic dermatitis, skin infection, skin wound, chickenpox, epidermolysis bullosa)
Allergy to fixation devices
Known immune deficient child
Refusal of the patient or of the holders of parental authority to participate
Life-saving emergency care
Patient already included in the study
Patient without social security coverage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura SOULARD
Phone
0251080582
Email
laura.soulard@ght85.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stephanie Chaillot
Organizational Affiliation
CHD VENDEE
Official's Role
Study Director
Facility Information:
Facility Name
CHD Vendee
City
La roche sur yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
stephanie chaillot
Email
stephanie.chaillot@ght85.fr
12. IPD Sharing Statement
Learn more about this trial
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
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