Galukande Moses, Duffy Kevin, Bitega Jean Paul, Rackara Sam, Bbaale Denis Sekavuga, Nakaggwa Florence, Nagaddya Teddy, Wooding Nick, Dea Monica, Coutinho Alex
International Hospital Kampala, Kampala, Uganda ; Surgery Department, Mulago Hospital, Kampala, Uganda.
International Medical Group, Kampala, Uganda.
PLoS One. 2014 Jan 28;9(1):e86631. doi: 10.1371/journal.pone.0086631. eCollection 2014.
Safe Male Circumcision is a proven approach for partial HIV prevention. Several sub Saharan African countries have plans to reach a prevalence of 80% of their adult males circumcised by 2015. These targets require out of ordinary organization, demand creation, timely execution and perhaps the use of SMC devices.
To profile Adverse Events rate and acceptance of PrePex, a non surgical device for adult male circumcision.
A prospective study, conducted at International Hospital Kampala, Uganda, between August and October 2012. Ethical approval was obtained from Uganda National Council of Science and Technology.
Of 1,040 men received to undergo SMC, 678 opted for PrePex, 36 were excluded at an initial physical examination screening. 642 were enrolled and consented, and another 17 were excluded before device placement. 625 underwent the procedure. Average age was 24 years (± 7). Twelve moderate AEs occurred among 10 participants 12/625, (1.9%). These were all reversible. Five had device displacement, one had an everted foreskin; five had bleeding after the device was removed and one had voiding difficulties. The majority (279 out of 300) of men interviewed complained of some pain within the week of placement. Mean pain score at device placement (using visual analogue scale) was 0.5, at device removal 4.5 and within 2 min of removal the pain score was 1.4. Over 70% of the devices were placed and removed by non-physician clinicians. Presented with a choice, 60% of men chose PrePex over surgical SMC. Close to 90% would recommend the device to their friends. Odour from the necrotic skin was a concern. Removals done 1-2 days earlier than day 7 were beneficial and conferred no extra risk.
AEs of a moderate or severe nature associated with PrePex were low and reversible. PrePex is feasible for mass safe male circumcision scaling up.
安全的男性包皮环切术是一种经证实的部分预防艾滋病病毒的方法。撒哈拉以南非洲的几个国家计划到2015年使80%的成年男性接受包皮环切术。这些目标需要非凡的组织、需求创造、及时执行，或许还需要使用男性包皮环切术器械。
概述PrePex（一种用于成年男性包皮环切术的非手术器械）的不良事件发生率和接受度。
2012年8月至10月在乌干达坎帕拉国际医院进行了一项前瞻性研究。获得了乌干达国家科学技术委员会的伦理批准。
在1040名接受男性包皮环切术的男性中，678人选择了PrePex，36人在初步体格检查筛查时被排除。642人登记并同意参与，另有17人在放置器械前被排除。625人接受了该手术。平均年龄为24岁（±7岁）。10名参与者中出现了12例中度不良事件（12/625），发生率为1.9%。这些都是可逆的。5人出现器械移位，1人包皮外翻；5人在器械移除后出血，1人排尿困难。接受访谈的大多数男性（300人中的279人）表示在放置器械后的一周内感到有些疼痛。放置器械时的平均疼痛评分（使用视觉模拟量表）为0.5，移除器械时为4.5，移除后2分钟内疼痛评分为1.4。超过70%的器械由非医生临床医生放置和移除。在有选择的情况下，60%的男性选择PrePex而非手术男性包皮环切术。近90%的人会向朋友推荐该器械。坏死皮肤的气味是一个问题。在第7天前1 - 2天进行移除是有益的，且不会带来额外风险。
与PrePex相关的中度或重度不良事件发生率较低且可逆。PrePex对于大规模安全男性包皮环切术的推广是可行的。
