A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Intraoperative Duration
研究概览
简要总结
To identify a 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 randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. 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.
The study will randomly assign participants to one of two groups:
- Unicirc device with tissue adhesive: 100 men
- Open surgical circumcision: 50 men
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
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
Open surgical circumcision
The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
干预措施: Open surgical circumcision (Procedure)
Unicirc device with tissue adhesive
Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
干预措施: Unicirc device with tissue adhesive (Device)
结局指标
主要结局
Intraoperative Duration
时间窗: 1 hour
Amount of time from first manipulation of tissue under local anesthesia to dressing
次要结局
- Number of Participants With Complete Wound Healing by Post-Surgery Week 4(Within 4 weeks after surgery)
- Pain Experienced(Within 2 days after surgery)
- Cosmetic Result(Within 6 weeks after surgery)
- Difficulty in Learning and Performing Technique(1 year)
- Overall Patient Satisfaction(Within 6 weeks after surgery)
研究者
Peter Millard
PI
Simunye Primary Health Care