Prophylactic mupirocin for peritoneal catheter exit sites reduces exit site infection (ESI) risk but engenders antibiotic resistance. We present early interim safety analysis of an open-label randomized study comparing polyhexamethylene biguanide (PHMB) and mupirocin. A total of 106 patients randomized to 53 in each group were followed up for a mean of 12.68 months per patient. On safety analysis, the PHMB group had a significantly greater ESI rate than the mupirocin group (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.09 to 0.80), leading to discontinuation of the trial. P eritoneal dialysis (PD) catheter exit site infections (ESI) can lead to peritonitis, morbidity, and mortality. Prophylaxis against ESI with the topical antibiotic mupirocin is recommended (1, 2, 3). Resistance to mupirocin is emerging, prompting a search for antiseptics, such as polyhexamethylene biguanide (PHMB), which will not confer resistance (4,5,6). Topical PHMB has an in vitro antibacterial activity comparable to that of mupirocin, is well tolerated, and is licensed as a wound care medical device in Europe (7,8,9,10). PHMB has a published record of safety in wound care; however, there is no published data on its use in prophylaxis of PD catheter ESI in humans.We designed a randomized clinical trial to compare ESI rates with PHMD and mupirocin. In order to detect a 50% reduction of Gram-negative ESI, we expected to recruit 200 patients. However, an intermediate safety analysis at 50% recruitment was required by the Ethics Committee and the Safety Monitoring Committee. The results of the interim safety analysis and its implication for the randomized trial are presented here. MATERIALS AND METHODSIn this interim safety analysis, we wished to determine that patients using PHMB would not have inferior ESI rates compared to those of patients randomized to mupirocin.Study group randomization and mupirocin/PHMB application. Patients who were receiving PD without active ESI or peritonitis or within 30 days of an episode gave consent to participate in the study and were randomized to daily application of either PHMB or mupirocin. Approximately 10 mg PHMB (Prontosan wound gel) was applied directly or with a cotton bud, or a "pea-size" amount of mupirocin ointment was applied using a cotton bud. All other catheter care protocols were identical for the 2 groups.Definition and diagnosis of ESI and peritonitis. ESIs were defined by diagnostic criteria in keeping with current ISPD and United Kingdom Renal Association guidelines (11). ESIs were diagnosed clinically from peritoneal catheter exit site purulent discharge associated with pericatheter swelling, redness, or tenderness. Swabs were obtained, but identifying a causative organism was not required for diagnosis. Infection rates were calculated as the number of infections divided by the total time at risk and expressed as episodes per 100 patient-months at risk. Peritonitis, defined by ISPD guidelines, was diagnosed by cloudy effluent with Ͼ100/l white cells, with Ͼ50% of these polymorpho...

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