跳至主要内容
临床试验/NCT01998360
NCT01998360已完成不适用

Rapid, Minimally-invasive Voluntary Adult Male Circumcision: a Quasi-experimental Study

Simunye Primary Health Care1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Intraoperative Duration

研究概览

简要总结

This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.

详细描述

Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.

According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."

This quasi-experimental compares the open surgical technique to an alternative minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The controls come from a separate randomized controlled trial (Unicirc 001) that was conducted just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy men at least 18 years of age requesting circumcision
  • No anatomical penile abnormalities or infections
  • Able to provide informed consent to participate
  • Willing to participate in follow-up visits -

排除标准

  • Current illness
  • Penile abnormality or infection which contraindicates or would complicate circumcision
  • History of bleeding disorder
  • Past reaction to local anesthetic

研究组 & 干预措施

Unicirc with tissue adhesive

Experimental

Excision of foreskin with Unicirc device and sealing wound with tissue adhesive

干预措施: Unicirc with tissue adhesive (Procedure)

Surgical control

Active Comparator

Surgical circumcision using forceps guided, dorsal slit, or sleeve method

干预措施: Surgical Control (Procedure)

结局指标

主要结局

Intraoperative Duration

时间窗: 1 hour

The number of minutes required to perform the surgical procedure

次要结局

  • Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks(1 month)
  • Cosmetic Result(6 weeks)
  • Number of Participants With Adverse Events(1 month)
  • Blood Loss(During procedure (up to 1 hour))

研究者

发起方
Simunye Primary Health Care
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Millard

PI

Simunye Primary Health Care

研究点 (1)

Loading locations...

相似试验

Rapid, Minimally-invasive Voluntary Adult Male... | 临床试验