Increased Peritoneal Dialysis Exit Site Infections Using Topical Antiseptic Polyhexamethylene Biguanide Compared to Mupirocin: Results of a Safety Interim Analysis of an Open-Label Prospective Randomized Study

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) andmupirocin. 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. Peritoneal dialysis (PD) catheter exit site infections (ESI) canlead 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