Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device

Abstract

BackgroundAs countries scale up adult voluntary medical male circumcision (VMMC) for HIV prevention, they are looking ahead to long term sustainable strategies, including introduction of early infant male circumcision (EIMC). Although a number of devices for EIMC are prequalified by the World Health Organization, evaluation of additional devices can provide policy-makers and clinicians the information required to make informed decisions. We undertook a field evaluation of the safety and acceptability of the AccuCirc device in Kisumu County, Kenya.MethodsProcedures were performed by four trained clinicians in two public facilities. Participants were recruited from surrounding public health facilities through informational talks at antenatal clinics, maternity wards, and maternal neonatal child health clinics. Healthy infants ages 0–60 days, with no penile abnormality, without a family history of bleeding disorder, with current weight-for-age within –2 Z-scores of WHO growth standards, and whose mother was at least 16 years of age were eligible for EIMC. The procedure was performed after administration of a penile dorsal nerve block using 2% lidocaine and administration of Vitamin K. The mother was given post-operative instructions on wound care and asked to remain in the clinic with the baby for an observational period of one hour, during which a face-to-face questionnaire was administered.ResultsOf 1259 babies screened, 704 were enrolled and circumcised. Median age of the infants was 16 days (IQR: 7–32.5) and of the mothers was 26 years (IQR: 22–30). Median time for the procedure was 19 minutes (IQR: 15–23). There were no serious adverse events (AE), and 20 (2.8%) moderate AEs, all of which were due to bleeding that required application of one to three sutures. There were 22 (3.8%) procedures in which the device did not fully incise the entire circumference of the foreskin and had to be completed using sterile scissors. 89.9% of mothers had knowledge of EIMC, but few (8.1%) had any knowledge of devices used for EIMC. Protection against HIV/AIDS was the most cited reason to circumcise a baby (65.3%), while the baby being ill (38.1%) and pain (34.4%) were the most cited barriers to uptake. 99% of mothers were “very satisfied” or “completely satisfied” with the procedure.ConclusionsThis evaluation of the AccuCirc device is the largest to date and indicates that the device is safe and acceptable, achieving high levels of parental satisfaction. The AccuCirc device should be considered for WHO prequalification to increase options for safe and sustainable provision of EIMC.

Efficacy of Dexmedetomidine Anesthesia plus Dorsal Penile Nerve Block in Pediatric Circumcision

“…However, the absence of ideal anesthesia, long surgical duration, and postoperative pain result in low treatment cooperation of the children, and general anesthesia is required in some cases for the completion of surgery [ 4 ]. In pediatric anesthesia, sevoflurane is considered ideal for induction and maintenance of anesthesia due to rapid induction and postoperative awakening without respiratory depression, but the child is highly predisposed to agitation during the awakening period [ 5 ]. Dexmedetomidine provides effective cardiovascular effects, analgesia, and sedation and therefore has been increasingly used in clinical anesthesia in recent years [ 6 ].…”

“…Postoperative pain, agitation, and difficulty in cooperation after pediatric circumcision are disadvantageous to the rapid postoperative recovery and prolonged hospitalization. Regional block enhances the effect of general anesthesia and provides good postoperative analgesia [ 5 ]. The ultrasound visualization technique applied to nerve block improves the blocking effect and reduces the damage to neurovascular and surrounding tissues and organs.…”

ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial

“…The rate of moderate AEs in a study of 704 infants undergoing EIMC with an atraumatic circumcision device (AccuCirc, Clinical Innovations, Murray, UT, USA) was 2•8%, compared with a rate of 0•9% with the ShangRing. 26 Although both the ShangRing and the Mogen clamp exceeded the expected 2•0% complication rate in this trial, when we limited our analysis to AEs that were definitely or probably related to the procedure, the percentage of AEs not related to pain was less than 1•0%. The absence of these severe complications might further reduce the barrier to EIMC uptake.…”