Accepted abstract presented in ICASA 2011; Addis Ababa, Ethiopia
Safety and Efficacy of the PrePex Device for Scale Up of Non-Surgical Circumcision when Performed by Nurses in Resource Limited Setting (Rwanda)
This is the first study to scientifically validate the safety and efficacy of task shifting of adult MC from physicians to nurses with a device. Ten nurses with no previous knowledge of the PrePex device and its use were trained for three days on the PrePex circumcision method. 590 healthy adult male volunteers were enrolled in the study and distributed between five teams of two nurses each. Efficacy: All 590 male subjects achieved the endpoint of complete circumcision with glans fully exposed.
Safety: There were two device-related moderate AEs (a rate of 0.33%) : (i) One case of bleeding 6 hours post-removal that required one suture and (ii) One case of pain, VAS 10, that occurred 1 day before removal, and the subject removed the foreskin and device by himself.
There were 3 non-device related AEs (a rate of 0.50%), all moderate, including one subject self -removal and one subject partial-removal of the device, contrary to specific instructions, and one case of erroneous placement that partially disturbed urination flow, and required replacement. The study statistically demonstrated that circumcision performed by nurses using the PrePex device is safe and effective.