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.

VMMC Devices—Introducing a New Innovation to a Public Health Intervention

“… 21 A study comparing the safety of using all available Shang-Ring sizes to using fewer sizes shows both schemes to be safe. 22 This type of operational study could translate into supply chain efficiencies for this device. Good outcomes are also seen with delivery of services in mobile units, which will allow programs to extend reach to more remote areas.…”

“…This supplement contains 16 articles from 8 countries examining different aspects of the introduction of devices into VMMC and focus on the following: Safety and acceptability of device introduction in Botswana, South Africa, Malawi, Zambia, Zimbabwe, Mozambique, and Kenya 14 – 20 , 22 – 24 The WHO-defined pathway for the evaluation of devices for VMMC programs for HIV prevention 13 Estimated unit costs of device-based VMMC and cost of device introduction 27 , 28 Impact of devices on demand for VMMC services 26 Provider training and client education. 21 , 25 …”

“…Safety and acceptability of device introduction in Botswana, South Africa, Malawi, Zambia, Zimbabwe, Mozambique, and Kenya 14 – 20 , 22 – 24 …”

“… 24 Analysis of clinical data from fixed and outreach VMMC sites in Kenya permitted identification of risk factors for delayed healing with the potential for delivery of targeted messages for at-risk clients. 22 Studies on healing with both devices reveal that men retain abstinence messages; study findings can be used to strengthen counseling messages to ensure adherence to instructions and avoidance of complications, such as device displacement/slippage. 17 , 25 The impact of devices on demand is analyzed using a market research–based approach to determine the population segments where increases in uptake resulting from introducing device options may be most likely to occur.…”