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Single-arm evaluation of the AccuCirc device for early infant male circumcision in Botswana
Rebeca M Plank1, Kathleen E Wirth, Nnamdi O Ndubuka
1*Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA; †Department of Immunology and Infectious Diseases, Harvard School of Public Health, Boston, MA; ‡Botswana-Harvard School of Public Health AIDS Initiative Partnership for HIV Research and Education, Gaborone, Botswana; §Department of Epidemiology, Harvard School of Public Health, Boston, MA; ‖Northern Inter-Tribal Health Authority, Prince Albert, Saskatchewan, Canada; ¶Botswana Ministry of Health, Gaborne, Botswana; #Departments of Internal Medicine and Pediatrics, Massachusetts General Hospital, Boston, MA; and; **Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, MA.
Insights
The AccuCirc device offers a safe and effective method for early infant male circumcision (EIMC) in resource-limited settings. High parental satisfaction and minimal adverse events indicate its potential for widespread adoption.
Area of Science:
- Medical Devices
- Pediatric Surgery
- Public Health
Background:
- Existing early infant male circumcision (EIMC) devices present significant limitations.
- Challenges in resource-limited settings include supply chain management and instrument disinfection.
Purpose of the Study:
- To evaluate the safety and efficacy of the novel AccuCirc device for EIMC.
- To assess parental satisfaction with the AccuCirc device in Botswana.
Main Methods:
- A prospective study involving 151 healthy, full-term male infants undergoing EIMC with the AccuCirc device.
- Infants were circumcised within the first 10 days of life in two hospitals.
- Adverse events and procedural outcomes were meticulously recorded.
Main Results:
- No major adverse events were reported; minor bleeding (5 cases) and local infection (1 case) were observed.
- Three cases required immediate provider completion of partial incisions without complications.
- Over 96% of mothers expressed high satisfaction and willingness to use the device for future sons.
Conclusions:
- The AccuCirc device demonstrated safety and efficacy in performing EIMC in a resource-limited setting.
- Its pre-assembled, sterile nature addresses logistical challenges, making it suitable for programmatic EIMC.
- The AccuCirc device is a promising option for improving EIMC services in resource-limited environments.
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 2 hospitals in Botswana. No major adverse events were observed. There was 1 local infection, 5 cases of minor bleeding, and 1 case of moderate bleeding. In 3 cases, the device made only partial incisions that were completed immediately by the provider without complications. Parental satisfaction was high: >96% of mothers stated that 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.

