Randomised trial of Prontosan wound gel for prevention of exit site infection in peritoneal dialysis patients

Active, not recruiting

• Conditions: Peritoneal dialysis patients and their peritoneal dialysis catheter exit site care.; MedDRA version: 9.1Level: LLTClassification code 10008831Term: Chronic ambulatory peritoneal dialysis

• Registration Number: EUCTR2006-006928-18-GB
• Lead Sponsor: Barts and The London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Prevalent PD patients (established on PD for a minimum of 3 months) without evidence of active exit site infection or within 30 days of an episode of peritonitis will be eligible for recruitment. Females of childbearing potential will be advised to use adequate contraception for the duration of the trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients unable to provide informed consent
-Known to have an allergy to Prontosan
-If patients are enrolled in another interventional study, they will be excluded if inclusion might invalidate the scientific validity of either studies or if there is safety concern.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified