Use of Ointments in Prevention of Catheter Related Infections in PD

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in approximately 25% of patients requiring dialysis in Canada. The most common complication is bacterial infection or 'peritonitis'. Peritonitis causes severe acute abdominal pain and may lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed on the regular use of a prophylactic ointment around the point where the catheter exits from the body. At the present time most centers in Canada routinely prescribe mupirocin ointment for use at the exit site, however newer ointments have become available. One such ointment is Polysporin Triple. The aim of this study is to determine if catheter related infections can be significantly reduced by the routine application of Polysporin Triple in comparison to mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed. Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18 months or until the first catheter related infection, death or catheter removal. The difference in catheter related infection rates will be compared between the two groups. We anticipate the results of this study will allow clinicians to prescribe the ointment most likely to reduce infections. By doing so this will reduce the complication rate associated with peritoneal dialysis and, ultimately improve survival.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Bacitracin; Mupirocin; Polymyxin B

Criteria

Inclusion Criteria:

1. Able and willing to provide informed consent*

2. Age over 18 years

3. Has a peritoneal dialysis catheter in situ and

• Is established on PD for more than 3 months (prevalent patients)

• Is undergoing training for or has initiated PD within the last 3 months (incident patients)

4. Medically stable (as defined by primary nephrologist)

5. Regularly applying mupirocin ointment to catheter exit site

Exclusion Criteria:

1. Presence of acute renal failure

2. Catheter related infection at the time of recruitment or within the previous 3 months

3. Use of an oral or IV antibiotic at the time of randomization or within the previous 1 week.

4. Known allergy to any component of gentamicin or mupirocin