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Background: Use of medical devices for voluntary medical male circumcision (VMMC) can offer several advantages. The ShangRing, a disposable single-use circumcision device, is simple to use, safe, and well-accepted in males 13 years old and above. We evaluated the safety, effectiveness, and acceptability of circumcision in males 10 years and above using a modified “no-flip” ShangRing technique, in addition to allowing spontaneous detachment of the device (as opposed to ring removal seven days after circumcision).
Methods: We enrolled men and boys seeking VMMC at two sites in Kenya. Participants were randomised to standard ShangRing removal seven days after circumcision vs. spontaneous device detachment. Weekly follow-up visits included evaluation of the degree of detachment if the ring was still in place, occurrence of adverse effects (AEs), and status of wound healing. Participants in the spontaneous detachment group could request device removal at any point during follow-up.
Results: 230 men and boys underwent ShangRing circumcision using the no-flip technique; 114 and 116 were randomised to the seven-day and spontaneous detachment groups, respectively. Mean ages in the two groups were 17.4 and 19.0 years, respectively. Mean circumcision times between the groups were similar (7.3±2.5 vs 7.0±2.6; p=0.4). All circumcisions were successfully completed using the ShangRing. Six (5.2%) and two (1.7%) moderate AEs were reported in the seven-day and spontaneous detachment groups, respectively, and were similar (p=0.17); there were no severe AEs. 84(72.4%) participants in the spontaneous detachment group wore the ring until it fell off; the remainder requested earlier removal. The probability of complete spontaneous detachment on seven, 14, and 28 days post-circumcision was 0.11, 0.63, and 1.00, respectively. Satisfaction with cosmetic results was high and similar in both groups?98.9% and 96.0% (p=0.3).
Conclusions: These results demonstrate the safety, acceptability, and effectiveness of the “no-flip” technique in males 10 years old and above, with 100% eligibility for all screened participants. Spontaneous detachment of the ring was safe and effective and was acceptable to a majority of men and boys. Use of the ShangRing as a single visit may significantly reduce the burden of service provision at health facilities.

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