Background: As countries in sub-Saharan Africa scale up medical male circumcision (MMC), they are considering long term sustainable strategies, including early infant male circumcision (EIMC). AccuCirc is a single use, disposable device that comes in a sterile pre-packaged kit and may have advantages over the Mogen clamp, which is the currently approved device for EIMC in Kenya. This study assesses the safety and acceptability of the AccuCirc device for EIMC in 600 male infants in Kisumu, Kenya.
Methods: Infant boys are recruited through informational talks and materials at antenatal and maternal child health clinics, maternity wards and during post-natal visits. Mothers ≥18 years and their healthy infants aged ≤60 days with no genital abnormalities nor history of bleeding disorder and meeting weight-for-age criteria are enrolled. They are given a dorsal penile block, and circumcised using the AccuCirc. During the one-hour post-op observation period, questionnaires are administered to mothers to assess knowledge about EIMC and levels of satisfaction. Three days after circumcision the wound is assessed and mothers are asked additional questions. Data are entered into RedCap and analyzed using STATA version 13.1.
Results: Among 541 mothers and babies screened, 359 (66%) were eligible. Of these 110 (31%) opted for a Mogen clamp procedure; 249 (69%) were enrolled and circumcised using AccuCirc. The median age of mothers was 26 years (IQR=22,30); 20% were unmarried and 62% had greater than a primary education. The median age of infants circumcised was 16 days (IQR=7,32); 27% were ≤7 days and 73% were ≤30 days. There were no severe adverse events (AEs); there were 17 (6.8%) moderate AEs, all due to bleeding that occurred immediately after device removal. All were resolved in less than one hour. There were also 9 (3.6%) incomplete cuts, which required completion using surgical scissors or the Mogen clamp. Bleeding and incomplete cuts were more frequent in older/heavier babies. No infections or injuries to the glans were observed.
Conclusions: The AccuCirc device may be an efficient and safe alternative for EIMC. Restricting procedures to babies ≤30 days may reduce AEs. These results contribute evidence needed as countries transition from adult toward infant circumcision.