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.

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