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

NCT ID: NCT03677063

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-08-01

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.

Conditions

Peritoneal Dialysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dressing

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

No dressing

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)

Group Type: EXPERIMENTAL

No dressing

Intervention Type: OTHER

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.

Interventions

No dressing

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SONIA GUILLOUET, PhD's

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

Caen University Hospital

Caen, , France

Countries

France

Other Identifiers

2018-A00379-46

Identifier Type: -

Identifier Source: org_study_id