Document Detail


A randomized trial of Mogen clamp versus Plastibell for neonatal male circumcision in Botswana.
MedLine Citation:
PMID:  23314413     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Rebeca M Plank; Nnamdi O Ndubuka; Kathleen E Wirth; Janet T Mwambona; Poloko Kebaabetswe; Barbara Bassil; Chiapo Lesetedi; Jane Magetse; Maggie Nkgau; Joseph Makhema; Mompati Mmalane; Tracy Creek; Kathleen M Powis; Roger Shapiro; Shahin Lockman
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  62     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-06-13     Completed Date:  2013-10-18     Revised Date:  2014-04-16    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e131-7     Citation Subset:  IM; X    
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MeSH Terms
Descriptor/Qualifier:
Botswana
Circumcision, Male / adverse effects,  instrumentation*
Female
Humans
Infant, Newborn
Male
Mothers
Personal Satisfaction
Questionnaires
Grant Support
ID/Acronym/Agency:
5K23AI084579/AI/NIAID NIH HHS; K23 AI084579/AI/NIAID NIH HHS; K23 HD070774/HD/NICHD NIH HHS
Comments/Corrections
Comment In:
J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):e12-3   [PMID:  24047973 ]
J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):e13-4   [PMID:  24043120 ]

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