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Background: This study was designed to validate the safety and efficacy of an adjusted PrePex procedure of removing the foreskin shortly after device application on day 0 (FRP). An initial assessment in Rwanda showed this procedure is feasible without injected anesthesia 30 to 60 minutes after device placement.
We validated that the updated procedure maintains the device non-surgical advantages while resolving some of the procedure limitations, such as anaerobic environment that may be prone for anaerobic bacteria growth, odour and foreskin hygiene.
Methods: Between March 2017 to May 2017, study procedures were performed in 2 mobile offices close to health care facilities in Lusaka and Livingstone, Zambia.
500 eligible male subjects scheduled for circumcision ages 13 to 49 were enrolled, the average age was 22.7 years (SD6.7).
The study was conducted in 2 phases:
Phase 1 (Establishing FRP protocol), 119 subjects.
Phase 2 (Validating the procedure), 381 subjects.
Results: For all 500 subjects, there was no need for injected anaesthesia for the FRP, 96.4% reported no pain at all, the average reported pain for the remaining 4.6% was 2.66 (VAS of 0 to 10 was used to evaluate subject reported pain).
The average waiting time from placement to FRP was 36 minutes.
During the 1st phase, while the FRP protocol was not yet established, there were 5 bleeding events (AE rate of 5%), 4 requiring device removal and sutures. At the 2nd phase, with an established FRP protocol, there were 2 bleeding events only, 1 requiring device removal and sutures (AE rate of 0.5%).The difference between the AE rates of both groups was statistically significant (p< 0.003).
Conclusions: This study demonstrates that removing the foreskin after device placement is safe and easy to perform while eliminating some of the device limitations, most importantly per WHO guideline it puts the device at the same tetanus risk level as surgical circumcision reducing the requirements for 2 tetanus toxoid contacting vaccine prior to PrePex.
This study will significantly contribute to the continuation of PrePex implementation in VMMC programs halted in 2016 following WHO tetanus guidelines.