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

Peritoneal Dialysis Clinical Trial

— PANCADIPE  

Official title:

Usefulness of Sterile Adhesive Dressing at the Exit-site of Peritoneal Dialysis Catheter: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677063
• Other study ID #: 2018-A00379-46
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Peritoneal Dialysis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months