Prospective Observational Study of the Shang Ring Device for Adult Medical Male Circumcision in a Routine Clinical Setting in Malawi

Abstract

We evaluated the safety and acceptability of the ShangRing device for male circumcision during routine clinical service delivery in Namitete, Malawi. We conducted a prospective observational study enrolling 500 HIV-negative men ages 18 to 49 years at St. Gabriel's Hospital. Participants returned for two follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement). We assessed pain, adverse events (AEs), acceptability, and healing. 500 men were screened; 498 were circumcised using the ShangRing and comprised the analysis population. Seven participants (1.4%) experienced moderate AEs related to circumcision. 93% were judged to be completely healed at or before the day 42 visit; 6% were judged to be healed later than the day 42 visit; 5 participants (1.0%) were lost to follow-up. 98% of men stated they were very satisfied with the appearance of their circumcised penis, and 99.6% would recommend ShangRing circumcision to family/friends. Adult male circumcision using the ShangRing was safe with a low AE rate at this service delivery site. Acceptability factors were also favorable. Addition of the ShangRing device could be beneficial to achieving the goals of the circumcision program in Malawi.

Simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment

“…Our results demonstrate that the no-flip ShangRing technique, whether with device removal at 7 days after circumcision or allowing it to fall off, is safe, effective, and acceptable to clients 10 years and older. Circumcision and device removal times, AE rates, time to clinical wound healing, and participant satisfaction with the no-flip technique appear similar to historical data from Africa with the original flip technique 171819202136. Data from these studies show AE rates of 1.0%–7.5%, circumcision times of 5–7 min, and removal times of 2–5 min; consistent with our results for the no-flip technique.…”

“…All were moderate, occurred during follow-up, were considered definitely related to the circumcision, and resolved with conservative management and without sequelae. Among participants with the no-flip technique and removal at 7 days, 5.3% (6/114; 95% CI: 1.2%–9.4%) had an AE, which was not higher, using a one-sided test, than the 3% from historical data with the flip technique ( P = 0.07) 17181920213637. Following circumcision with the no-flip technique and spontaneous detachment, 1.7% (2/116; 95% CI: 0–4.1%) of participants had an AE, also not different from previously published studies ( P = 0.79).…”

“…For our primary objective, we examined data from previous ShangRing studies in Africa that used the flip technique with removal at 7 days. The range of AE rates was 0.8%–7.6% 17181920213637. We used 3% to represent the baseline AE rate for the flip technique.…”

“…VMMC devices may reduce some challenges in service scale-up needed to reach these ambitious goals, making the procedure simpler and faster 121316. The ShangRing, a single-use collar clamp circumcision device, is safe, easy to use, and acceptable in Africa 1718192021. It received World Health Organization (WHO) prequalification for use in males 13 years and older following studies in Africa (the ShangRing has US FDA 510(k) clearance for use in adult males) 16222324.…”

Commentary on “simplifying the ShangRing technique for circumcision in boys and men: use of the no-flip technique with randomization to removal at 7 days versus spontaneous detachment”

“…Much progress has been made over the past 10 years since that original article was published in Asian Journal of Andrology in 2008. In studies conducted in Kenya, Malawi, Uganda, and Zambia, the ShangRing has been shown to be safe, effective, and well-accepted by men and boys and by providers of adult and adolescent VMMC services 67891011. The device received a CE mark in 2008, FDA 510(k) clearance in 2012, and the WHO prequalification in 2015.…”