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Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter (PANCADIPE)

Primary Purpose

Peritoneal Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
No dressing
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peritoneal Dialysis focused on measuring peritoneal dialysis, dressing, exit-site, catheter, infection

Eligibility Criteria

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

Inclusion Criteria:

  • patient who has been informed and has given free and informed consent
  • patient affiliated to a social security scheme

Exclusion Criteria:

  • inclusion of the patient in another biomedical research protocol that influences the risk of infection
  • burial of the catheter before the initiation of dialysis treatment second attempt at treatment with peritoneal dialysis following catheter removal and resection
  • patient under curatorq
  • pregnant woman

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Dressing

No dressing

Arm Description

It is the historical cohort which is composed of patients over 18 years of age treated by peritoneal dialysis in the nephrology department of Universty Hospital of Caen Normandie. Patients with the same non-inclusion criteria as the experimental group will not be included. The data will be extracted from the Registry of Peritoneal Dialysis of French Language. The number of patients included from the register can not be fixed in advance; this number will correspond to the 4-year follow-up at the start date of the study to ensure at least two years of patient follow-up Usually care First dressing 5 or 10 days after the pose of the catheter : Cleaning emergence with antiseptic soap Rinsing with saline Drying Application of a hazelnut mupirocin on the exit-site Application of an occlusive dressing on the exit-site Then, care is the same. Exit-site care is performed daily if the patient takes a shower or twice a week.

No application of sterile dressing at the exit-site of periotoneal dialysis catheter for all patients (30 days after the placement of the peritoneal dialysis catheter)

Outcomes

Primary Outcome Measures

Infectious event
Time until the occurrence of an infectious event: Infection of Staphylococcus aureus peritoneal dialysis fluid (SA) within 24 months of follow-up Infection of peritoneal dialysis fluid other than AS within 24 months of follow-up Emergence infection during 24 months of follow-up Peritonitis at SA and simultaneous presence of SA at emergence within 24 months of follow-up

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
March 2, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT03677063
Brief Title
Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter
Acronym
PANCADIPE
Official Title
Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

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
Infection of peritoneal dialysis fluid is a major complication in patients treated with peritoneal dialysis (PD). The aim of catheter emergence care is to reduce bacterial contamination of the peritoneum. The recommendations of the International Society of Peritoneal Dialysis do not provide information on the frequency of care delivery or the usefulness of a sterile adhesive dressing. Thus each treatment center applies a protocol of its own. Dressing is common practice although its safety and interest are not demonstrated. The usefulness of dressing is still to be demonstrated. On the other hand, the efficacy of the application in prevention of a cream of mupirocin at emergence on the reduction of the risk of infection with staphylococcus aureus (SA), the most frequent germ found in peritonitis, has been demonstrated. A Spanish study showed that during a peritoneal infection at SA the site most frequently colonized by a similar strain of SA was the emergence of the catheter. It can be considered that an infection of the dialysis liquid in PD is not only related to the quality of emergency care but also to manipulations during exchanges. Given the number of patients involved in PD in France, it is difficult to obtain sufficient power to formally demonstrate the non-inferiority of the absence of dressing. Therefore, the investigators propose a descriptive, exploratory study of events that may occur in PD when a dressing is not applied. This is a step prior to performing a multicenter randomized comparative study that will aim to show the non-inferiority of the absence of dressing compared to the application of a dressing on the incidence of fluid infection. peritoneal dialysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis
Keywords
peritoneal dialysis, dressing, exit-site, catheter, infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dressing
Arm Type
No Intervention
Arm Description
It is the historical cohort which is composed of patients over 18 years of age treated by peritoneal dialysis in the nephrology department of Universty Hospital of Caen Normandie. Patients with the same non-inclusion criteria as the experimental group will not be included. The data will be extracted from the Registry of Peritoneal Dialysis of French Language. The number of patients included from the register can not be fixed in advance; this number will correspond to the 4-year follow-up at the start date of the study to ensure at least two years of patient follow-up Usually care First dressing 5 or 10 days after the pose of the catheter : Cleaning emergence with antiseptic soap Rinsing with saline Drying Application of a hazelnut mupirocin on the exit-site Application of an occlusive dressing on the exit-site Then, care is the same. Exit-site care is performed daily if the patient takes a shower or twice a week.
Arm Title
No dressing
Arm Type
Experimental
Arm Description
No application of sterile dressing at the exit-site of periotoneal dialysis catheter for all patients (30 days after the placement of the peritoneal dialysis catheter)
Intervention Type
Other
Intervention Name(s)
No dressing
Intervention Description
Then, care is the same and exit-site remains covered with an occlusive dressing to promote tunnel epithelialization and healing. The shower is forbidden during this period.
Primary Outcome Measure Information:
Title
Infectious event
Description
Time until the occurrence of an infectious event: Infection of Staphylococcus aureus peritoneal dialysis fluid (SA) within 24 months of follow-up Infection of peritoneal dialysis fluid other than AS within 24 months of follow-up Emergence infection during 24 months of follow-up Peritonitis at SA and simultaneous presence of SA at emergence within 24 months of follow-up
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient who has been informed and has given free and informed consent patient affiliated to a social security scheme Exclusion Criteria: inclusion of the patient in another biomedical research protocol that influences the risk of infection burial of the catheter before the initiation of dialysis treatment second attempt at treatment with peritoneal dialysis following catheter removal and resection patient under curatorq pregnant woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FRANCOIS FOURNEL
Phone
+33231063106
Email
fournel-f@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
MAGALI BESTIN
Phone
+33231063106
Email
bestin-m@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SONIA GUILLOUET, PhD's
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia GUILLOUET, PhD's
Phone
+33 231272577
Email
guillouet-s@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter

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