Factors Associated With Delayed Healing in a Study of the PrePex Device for Adult Male Circumcision in Kenya.

ABSTRACT

OBJECTIVES: To explore factors associated with healing requiring more than 6 weeks after placement of the PrePex device for adult medical male circumcision. METHODS: We enrolled 427 men ages 18-49 years in an observational study of PrePex at 1 urban and 2 peripheral clinics in western Kenya. Participants were scheduled for device removal at day 7 and a follow-up visit at day 42 (allowable range, 40-44) at which the provider recorded wound status, with complete healing defined as a dry wound without any scab, later confirmed by site investigator review of digital penile photographs. We performed univariate and multivariate logistic regression to explore associations between selected demographic, surgical, and follow-up factors and delayed healing (not healed by day 42 visit). RESULTS: Of the 427 men, 341 completing a day 42 visit with physical examination and recorded healing status were included. Fifty-four percent of included men were healed by day 42 visit. Factors associated with delayed healing in univariate analysis and remaining significant in the multivariate analysis were as follows age 25 years or older [odds ratio (OR) 1.8; 95% confidence interval (CI) 1.4 to 2.4], an adverse event by day 44 (OR 1.4; 95% CI 1.03 to 2.0), and severe pain during device removal (protective association OR 0.7; 95% CI 0.5 to 0.99). CONCLUSIONS: Older age (25+ years), occurrence of an adverse event, and lesser self-reported pain at device removal were associated with delayed wound healing. If confirmed by larger surveillance studies, these results should be incorporated into the counseling given to male circumcision clients.