The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study.
The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study.
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DOI：
10.1371/journal.pone.0100008
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Gray RH
中科院分区：
文献类型：
--
作者：
Kigozi G;Musoke R;Watya S;Kighoma N;Nkale J;Nakafeero M;Namuguzi D;Serwada D;Nalugoda F;Sewankambo N;Wawer MJ;Gray RH
评估PrePex器械用于乌干达农村男性包皮环切术（MMC）的安全性和可接受性。在一项观察性研究中，要求择期MMC的18岁及以上未感染HIV、未行包皮环切术的男性被告知PrePex和背侧缝术方法，并可自由选择其首选手术。100名男性接受PrePex，以评估初步安全性（目的1）。另外329名男性，250名选择PrePex，79名选择背侧缝型，在安全性监查委员会批准后入组（目的2）。在7天时对男性进行随访，以评估不良事件（AE）并取出PrePex器械。在4周时评估伤口愈合，随后每周随访一次，直至完全愈合。5.7%的男性因包皮过紧或包茎/粘连而禁忌使用PrePex器械。在入组的429名男性中，350名（82.0%）接受了PrePex器械，79名（18.0%）接受了背侧纵切术。329名男性中有250名（76.0%）被邀请在2种手术中选择Prepex。PrePex有9起AE（2.6%），其中5起（1.4%）为重度并发症，4起是由于患者自行取出器械导致水肿和尿路梗阻，需要紧急手术包皮环切术，1起是由于取出器械后伤口裂开。71.8%的男性在去除PrePex前报告了难闻的气味。使用PrePex的累积伤口完全愈合率在第4周为56.7%，第5周为84.8%，第6周为97.6%，第7周为98.6%，而使用背侧缝的累积伤口完全愈合率在第4周为98.7%（p<0.0001）。PrePex器械被广泛接受，但愈合速度慢于背侧纵切手术。严重并发症主要发生在PrePex自行取出后，需要快速进入急诊手术机构。需要返回移除和延迟愈合可能会增加计划成本和客户负担。
To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda. In an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing. The PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001). The PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.
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