Safety of over Twelve Hundred Infant Male Circumcisions Using the Mogen Clamp in Kenya

University of Massachusetts Medical School, United States of America
PLoS ONE (Impact Factor: 3.23). 10/2012; 7(10):e47395. DOI: 10.1371/journal.pone.0047395
Source: PubMed


Several sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya.
AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤2 months and weighing ≥2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors.
A total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR = 1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed.
IMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life.

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    • "Misconceptions about how the procedure is conducted and the risks associated with it were commonly cited; information, education, and communication (IEC) materials will need to provide understandable and accurate information to explain the procedure and that when conducted by appropriately trained and experienced personnel, IMC is safe, does not require sutures and is usually characterised by minimal bleeding [15, 18]. Additionally, IEC materials need to also explain issues around pain management and infection control (and that if an infection occurs, it usually involves just the skin and can be easily treated) [15, 18]. Concerns around the possibility that infant MC may itself be a source of HIV infection need to be specifically addressed. "
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    ABSTRACT: Infant male circumcision (IMC) may be more effective at preventing HIV than adult male circumcision as the procedure is carried out before the individual becomes sexually active. Successful scale-up will depend on identifying and overcoming parental concerns that may act as barriers for IMC. We conducted a systematic review to identify qualitative studies reporting on parental reasons for non-adoption of IMC for HIV prevention in sub-Saharan Africa. Thematic synthesis was subsequently conducted. Five descriptive themes were identified; these were later condensed into two main analytical themes: “poor knowledge” and “social constructs”. While barriers and motivators are to some degree context specific, this review suggests that there are common themes that need to be addressed across the region if uptake of IMC for HIV prevention is to be widely adopted. Study findings are therefore likely to have broad implications for IMC roll out. Electronic supplementary material The online version of this article (doi:10.1007/s10461-014-0835-7) contains supplementary material, which is available to authorized users.
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    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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    ABSTRACT: : Existing devices for early infant male circumcision (EIMC) have inherent limitations. We evaluated the newly developed AccuCirc device by circumcising 151 clinically well, full-term male infants with birth-weight ≥ 2.5 kg within the first 10 days of life from a convenience sample in two hospitals in Botswana. No major adverse events were observed. There was one local infection, five cases of minor bleeding and one case of moderate bleeding. In three cases the device made only partial incisions that were completed immediately by the provider without complications. Parental satisfaction was high: > 96% of mothers stated they would circumcise a future son. The pre-assembled, sterile AccuCirc kit has the potential to overcome obstacles related to supply chain management and on-site instrument disinfection that can pose challenges in resource-limited settings. In our study the AccuCirc was safe and it should be considered for programmatic EIMC in resource-limited settings.
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