Safety and efficacy of the PrePex device for rapid scale-up of male circumcision for HIV prevention in resource-limited settings.

OBJECTIVE: To assess the safety and efficacy of the PrePex device for nonsurgical circumcision in adult males as part of a comprehensive HIV prevention program in Rwanda. METHODS: Single-center 6-week noncontrolled study in which healthy men underwent circumcision using the PrePex device which employs fitted rings to clamp the foreskin leading to distal necrosis. In the first phase of the study the feasibility of the procedure was tested on 5 subjects in a sterile environment; in the main phase an additional 50 subjects were circumcised in a nonsterile setting by physicians or a nurse. Outcome measures included the rate of successful circumcision time to complete healing pain and adverse events. RESULTS: In the feasibility phase all 5 subjects achieved complete circumcision without adverse events. In the main phase all 50 subjects achieved circumcision with 1 case of diffuse edema after device removal which resolved with minimal intervention. Pain was minimal except briefly during device removal (day 7 after placement in most cases). The entire procedure was bloodless requiring no anesthesia no suturing and no sterile settings. Subjects had no sick/absent days associated with the procedure. Median time for complete healing was 21 days after device removal. There were no instances of erroneous placement and no mechanical problems with the device. CONCLUSION: The PrePex device was safe and effective for nonsurgical adult male circumcision without anesthesia or sterile settings and may be useful in mass circumcision programs to reduce the risk of HIV infection particularly in resource-limited settings.