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

Background: As 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. Methods: Procedures 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. Results: Of 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. Conclusions: This 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.背景：随着各国扩大成人自愿医学男性包皮环切术（Voluntary Medical Male Circumcision, VMMC）用于艾滋病预防，各方正着眼于长期可持续策略，包括推广婴儿早期男性包皮环切术（Early Infant Male Circumcision, EIMC）。尽管世界卫生组织（World Health Organization, WHO）已对多款EIMC器械完成预认证，但对额外器械开展评估，可为政策制定者与临床医师提供知情决策所需的信息。本研究针对肯尼亚基苏木县的AccuCirc器械开展安全性与可接受性现场评估。 方法：由4名经过培训的临床医师在2所公立医疗机构开展手术。研究对象通过产前门诊、产科病房及母婴健康门诊的宣讲活动，从周边公立卫生机构招募。纳入标准为：年龄0~60天的健康男婴，无阴茎畸形，无出血性疾病家族史，当前年龄别体重处于世界卫生组织生长标准的-2 Z评分范围内，且母亲年龄至少16岁。手术采用2%利多卡因实施阴茎背神经阻滞，并给予维生素K后进行。术后向母亲提供伤口护理指导，并要求其陪同婴儿在诊所留观1小时，期间完成面对面问卷调查。 结果：共计1259名婴儿接受筛查，其中704名入组并完成包皮环切术。婴儿的中位年龄为16天（四分位距：7~32.5），母亲的中位年龄为26岁（四分位距：22~30）。手术中位时长为19分钟（四分位距：15~23）。未发生严重不良事件（Adverse Event, AE），共出现20例（2.8%）中度不良事件，均为出血情况，需缝合1~3针。另有22例（3.8%）手术中，器械未能完全切开包皮全周，需使用无菌剪刀完成手术。89.9%的母亲知晓EIMC，但仅极少数（8.1%）了解EIMC所用的器械。预防艾滋病是母亲选择为婴儿实施包皮环切术的最主要原因（65.3%），而婴儿患病（38.1%）与手术疼痛（34.4%）则是最主要的入组障碍。99%的母亲对手术表示“非常满意”或“完全满意”。 结论：本项针对AccuCirc器械的评估为目前规模最大的同类研究，结果显示该器械安全性与可接受性良好，家长满意度处于较高水平。建议将AccuCirc器械纳入世界卫生组织预认证目录，以拓展安全且可持续的EIMC服务供给选择。