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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677063
Other study ID # 2018-A00379-46
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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