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A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana

Plank, Rebeca M. MD; Ndubuka, Nnamdi O. MBBS, MPH; Wirth, Kathleen E. ScD; Mwambona, Janet T. MD, MPH; Kebaabetswe, Poloko MPH, PhD; Bassil, Barbara MD, MBA; Lesetedi, Chiapo MB, CHb, BAO(NUI), AFRCSI(RCSI); Magetse, Jane RN; Nkgau, Maggie RN

 J Acquir Immune Defic Syndr. 2013 Apr, 15;62(5), Pages 131-7.

Editor’s comment: Prof. Jim Thornton: Deaths after neonatal male circumcision
Some public health advocates of male circumcision to prevent HIV infection, now encourage neonatal male circumcision. This controversial trial performed by North American researchers in Botswana compared two methods and concluded that both were safe. Although complication rates were 10%, and 3/300 babies died, the authors concluded that none of the deaths were related to the procedure.

Abstract

Background: Male circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings.

Methods: We performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devices for NMC. Follow-up visits occurred at 6 weeks and 4 months postpartum. Adverse events, parental satisfaction, and staff impressions were recorded.

Results: Of 302 male neonates randomized, 300 (99%) underwent circumcision, 153 (51%) with Mogen clamp, and 147 (49%) with Plastibell. There were no major adverse events in the Mogen clamp arm, but there were 2 major adverse events in the Plastibell arm (both were a proximally migrated ring that had to be removed by study staff). Minor adverse events were more common with the Mogen clamp compared with the Plastibell, specifically removal of too little skin and formation of skin bridges or adhesions (12 versus 1 and 11 versus 3, respectively, all P < 0.05). Five (3%) infants in the Mogen clamp arm and none in the Plastibell arm had minor bleeding (P = 0.03). More than 94% of mothers reported being highly or completely satisfied with the procedure.

Conclusions: NMC can be performed in Botswana with a low rate of adverse events and high parental satisfaction. Although the risk of migration and retention of the Plastibell is small, the Mogen clamp may be safer for NMC in regions where immediate emergent medical attention is not available.

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Commentaries by Editor Prof. Jim Thornton