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  5. Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting

Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting

File(s)
40998526.pdf (399.43 KB)
Permanent Link(s)
https://hdl.handle.net/1813/121524
Collections
Department of Urology
Author
Posada Calderon, L.
Basourakos, S.P.
Ballman, K.V.
Ho, K.
Barone, M.A.
Awori, Q.
Ouma, D.
Oketch, J.
Christensen, A.
Hellar, A.
Makokha, M.
Isangu, A.
Salim, R.
Lija, J.
Gray, R.
Kiboneka, S.
Anok, A.
Kigozi, G.
Nakabuye, R.
Ddamulira, C.
Odiya, S.
Goldstein, M.
Li, P.S.
Lee, R.K.
Abstract

INTRODUCTION: Male circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments. METHODS: Healthy male infants aged 1-60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical. TRIALS: gov, NCT03338699, and is complete. RESULTS: From the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6-13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days. CONCLUSION: ShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. This indicates that the ShangRing EIMC can be considered a long-term strategic approach to accelerate the scale-up of MC in Sub-Saharan Africa. TRIAL REGISTRATION NUMBER: NCT03338699.

Journal / Series
BMJ global health
Volume & Issue
10(9)
Date Issued
2025-09-25
Publisher
BMJ Publishing Group
Keywords
WCM Library Coordinated Deposit
•
Humans
•
Infant
•
Infant, Newborn
•
Male
•
Circumcision, Male/instrumentation/methods/adverse effects
•
HIV Infections/prevention & control
•
Kenya
•
Patient Satisfaction
•
Uganda
•
Wound Healing
•
Hiv
•
Health policy
•
Prevention strategies
•
Urology
Related DOI
https://doi.org/10.1136/bmjgh-2024-017903
Previously Published as
Posada Calderon L, Basourakos SP, Ballman KV, Ho K, Barone MA, Awori Q, Ouma D, Oketch J, Christensen A, Hellar A, Makokha M, Isangu A, Salim R, Lija J, Gray R, Kiboneka S, Anok A, Kigozi G, Nakabuye R, Ddamulira C, Odiya S, Goldstein M, Li PS, Lee RK. Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting. BMJ global health. 2025;10(9). doi: 10.1136/bmjgh-2024-017903. PMID: 40998526.
Rights
Attribution 4.0 International
Rights URI
https://creativecommons.org/licenses/by/4.0/
Type
article

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