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ORIGINAL ARTICLES |
Department of Medicine, University of Toronto, and Division of Nephrology, University Health Network, Toronto, Ontario, Canada
Correspondence to: S.V. Jassal, University Health Network, 8NU-857, 200 Elizabeth Street, Toronto, M5G 2C4 Ontario, Canada. vanita.jassal{at}uhn.on.ca
Background: Peritonitis remains the most serious
complication of peritoneal dialysis (PD). Gram-positive organisms are among
the most common causes of PD peritonitis; however, recent trends show
increasing rates of gram-negative and fungal infections. Strategies to prevent
peritonitis include the use of prophylactic topical mupirocin at the site
where the PD catheter exits from the abdominal wall; however, mupirocin does
not afford protection against gram-negative or fungal infections. The aim of
this study is to determine if the incidence of catheter-related infections
(exit-site infection, tunnel infection, or peritonitis) is significantly
reduced by the routine application of Polysporin Triple antibiotic ointment
(Pfizer Canada, Markham, Ontario, Canada) in comparison to mupirocin
ointment.
Methods and Design: The Mupirocin Versus Polysporin
Triple Study (MP3) is a multicenter, randomized, double-blinded controlled
study comparing Polysporin Triple (P3) against the current standard of care.
The aim of the study is to recruit 200 patients being treated with or starting
on PD and randomize them to receive either mupirocin or P3 at the catheter
exit site. Patients will be followed for 18 months or until death or transfer
from PD to an alternate treatment modality. The primary outcome will be the
time to first catheter-related infection. Catheter-related infections will be
strictly defined using current guidelines and categorized into exit-site
infections, infective peritonitis, or tunnel infections. The primary analysis
will be an intention-to-treat analysis.
Discussion: The results of this study will help
determine if the use of P3 is superior to mupirocin ointment in the prevention
of catheter-related infections and will help guide evidence-based best
practices.
KEY WORDS: Double blind, randomized controlled trial; peritonitis; exit site; mupirocin ointment.
Received 17 May 2007; accepted 6 July 2007.
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