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使用Unicirc进行的无需打针、单次就诊的成年男性包皮环切术:一项多中心现场试验。

No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial.

作者信息

Millard Peter S, Goldstuck Norman D

机构信息

University of New England, Portland, Maine, United States of America.

Faculty of Medicine and Health Sciences, Stellenbosch University and Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa.

出版信息

PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.

Abstract

BACKGROUND

Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. Current adult circumcision methods need improvement.

METHODS

Field trial in 3 primary care centres. Minimally invasive VMMC using the Unicirc instrument following topical lidocaine/prilocaine anesthetic. Men were followed up at 1 and 4 weeks.

RESULTS

We circumcised 110 healthy volunteers. Two men complained of transient burning pain during circumcision, but none required injectable anaesthesia. Median blood loss was 1ml and median procedure time was 9.0 min. There were 7 (6.3%) moderate complications (5 (4.5%) post-operative bleeds requiring suture and 2 (1.8%) post-operative infections) affecting 7 men. No men experienced significant wound dehiscence. 90.4% of men were fully healed at 4 weeks of follow-up and all were highly satisfied.

CONCLUSIONS

Use of topical anaesthesia obviates the need for injectable anesthetic and makes the Unicirc procedure nearly painless. Unicirc is rapid, easy to learn, heals by primary intention with excellent cosmetic results, obviates the need for a return visit for device removal, and is potentially cheaper and safer than other methods. Use of this method will greatly facilitate scale-up of mass circumcision programs.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02091726.

摘要

背景

男性自愿医学包皮环切术(VMMC)是一项优先的艾滋病毒预防干预措施。目前的成人包皮环切术方法需要改进。

方法

在3个初级保健中心进行现场试验。在局部利多卡因/丙胺卡因麻醉后,使用Unicirc器械进行微创VMMC。对男性进行1周和4周的随访。

结果

我们为110名健康志愿者进行了包皮环切术。两名男性在包皮环切术中抱怨有短暂的灼痛,但无人需要注射麻醉。中位失血量为1毫升,中位手术时间为9.0分钟。有7例(6.3%)中度并发症(5例(4.5%)术后出血需要缝合,2例(1.8%)术后感染)影响7名男性。没有男性出现明显的伤口裂开。90.4%的男性在随访4周时完全愈合,所有人都非常满意。

结论

使用局部麻醉消除了对注射麻醉的需求,使Unicirc手术几乎无痛。Unicirc手术快速、易于学习,一期愈合且美容效果极佳,无需复诊取出器械,并且可能比其他方法更便宜、更安全。使用这种方法将极大地促进大规模包皮环切项目的扩大。

试验注册

ClinicalTrials.gov NCT02091726。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5567/4379010/5ce0abdf9fac/pone.0121686.g001.jpg

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