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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
A randomized controlled trial comparing mupirocin and polysporin triple ointments in peritoneal dialysis patients:
Rory F McQuillan1, Ernest Chiu, Sharon Nessim
1Division of Nephrology, University Health Network, Toronto, Canada.
Background And Objectives:
Infectious complications remain a significant cause of peritoneal dialysis (PD) technique failure. Topical ointments seem to reduce peritonitis; however, concerns over resistance have led to a quest for alternative agents. This study examined the effectiveness of applying topical Polysporin Triple ointment (P(3)) against mupirocin in a multi-centered, double-blind, randomized controlled trial.
Design, Setting, Participants, & Measurements:
PD patients routinely applied either P(3) or mupirocin ointment to their exit site. Patients were followed for 18 months or until death or catheter removal. The primary study outcome was a composite endpoint of exit-site infection (ESI), tunnel infection, or peritonitis.
Results:
Seventy-five of 201 randomized patients experienced a primary outcome event (51 peritonitis episodes, 24 ESIs). No difference was seen in the time to first event for P(3) (13.2 months; 95% confidence interval, 11.9-14.5) and mupirocin (14.0 months; 95% confidence interval, 12.7-15.4) (P=0.41). Twice as many patients reported redness at the exit site in the P(3) group (14 versus 6, P=0.10). Over the complete study period, a higher rate per year of fungal ESIs was seen in patients using P(3) (0.07 versus 0.01; P=0.02) with a corresponding increase in fungal peritonitis (0.04 versus 0.00, respectively; P<0.05).
Conclusions:
This study shows that P(3) is not superior to mupirocin in the prophylaxis of PD-related infections. Colonization of the exit site with fungal organisms is of concern and warrants further study. As such, the use of P(3) over mupirocin is not advocated in the prophylaxis of PD-related infections.
Insights
Polysporin Triple ointment (P(3)) did not prove superior to mupirocin for preventing peritoneal dialysis infections. P(3) use was associated with increased fungal infections at the exit site and peritonitis.
Area of Science:
- Nephrology
- Infectious Diseases
- Clinical Trials
Background:
- Infectious complications are a major cause of peritoneal dialysis (PD) technique failure.
- Topical ointments are used to reduce peritonitis, but concerns about resistance drive the search for alternatives.
- This study investigated Polysporin Triple ointment (P(3)) as an alternative to mupirocin.
Purpose of the Study:
- To compare the effectiveness of topical Polysporin Triple ointment (P(3)) versus mupirocin in preventing PD-related infections.
- To evaluate the composite endpoint of exit-site infection (ESI), tunnel infection, or peritonitis.
Main Methods:
- A multi-centered, double-blind, randomized controlled trial was conducted.
- PD patients applied either P(3) or mupirocin ointment to their exit site.
- Patients were followed for 18 months, with primary outcomes assessed.
Main Results:
- No significant difference was observed in the time to the first primary outcome event between P(3) and mupirocin groups (13.2 vs. 14.0 months).
- The P(3) group showed a higher incidence of exit-site redness.
- A significant increase in fungal exit-site infections and fungal peritonitis was noted in the P(3) group compared to mupirocin.
Conclusions:
- Polysporin Triple ointment (P(3)) is not superior to mupirocin for preventing PD-related infections.
- Increased fungal colonization at the exit site with P(3) use is a concern.
- The use of P(3) over mupirocin for PD infection prophylaxis is not recommended based on these findings.
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