Comparison of the Shang Ring With Conventional Surgical Methods: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Pain scores on the Visual Analog Scale
研究概览
简要总结
This is a randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia).
详细描述
A randomized control trial of 400 adult male circumcision procedures with a one to one ratio between Shang Ring and the in-country standard surgical technique (forceps guided in Kenya and dorsal slit in Zambia)
Population: 400 men (200 at each site), HIV sero-negative men, ages 18-54, living in/around the two clinic sites seeking adult male circumcision
Duration: 2-4 months of recruitment; 60 days follow-up per participant; total expected duration of approximately 6 months in the field
Primary Objectives: (1) Compare the pain and acceptability of the Shang Ring procedure with the forceps guided surgical circumcision technique (Kenya) and the dorsal slit technique (Zambia) (2) Compare the safety and the course of wound healing, including the time to complete healing, between the Shang Ring adult male circumcision procedure and the standard surgical circumcision procedures (forceps guided in Kenya & dorsal slit in Zambia); (3) Compare the ease of the Shang Ring method versus standard circumcision surgical procedures
Primary Endpoints: (1) To compare the pain & acceptability of the circumcision methods, we will evaluate the following: post-operative pain; time to return to normal activity; patients' opinions of the Shang Ring and conventional procedures, and satisfaction with cosmetic results.
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 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Must be aged 18 and 54 years;
- •Must be uncircumcised (on examination);
- •Must be in good general health;
- •Must be HIV sero-negative, with documentation of testing no more than one week before the procedure;
- •Must be free of genital ulcerations or other visible signs of STI (on examination);
- •Must be able to understand study procedures and requirements of study participation;
- •Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision;
- •Must freely consent to participate in the study and sign a written informed consent form;
- •Must have a cell phone or access to a cell phone; and,
- •Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
排除标准
- •Has a known allergy or sensitivity to lidocaine or other local anesthesia;
- •Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- •Has known bleeding/clotting disorder (e.g. hemophilia); or
- •Has an active genital infection, anatomic abnormality or other condition (e.g. severe obesity, diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study;
- •Is not currently participating in another biomedical study.
研究组 & 干预措施
1
One group of men will undergo a circumcision using the Shang Ring and men are to return for regular follow-up visits to evaluate pain and wound healing. . The Shang Ring will be removed at 7 days, and the last scheduled follow-up visit is at 60 days.
干预措施: Shang Ring (Device)
2
One group of men will undergo a conventional circumcision using a WHO recommended surgical technique, either the forceps-guided method or the dorsal slit method. Men are to return for regular follow-up visits to evaluate pain and wound healing, with the last scheduled follow-up visit at 60 days.
干预措施: Male circumcision (Procedure)
结局指标
主要结局
Pain scores on the Visual Analog Scale
时间窗: Within the first 48 hours after circumcision
We will ask participants about pain they experienced during and soon after the procedure, and during the recovery period.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to six weeks after surgery
We will classify circumcision-related adverse events, using the detailed definitions of moderate and severe events per standardized protocol definitions, based on WHO recommendations. Most post-operative complications are apparent within six weeks of surgery.
次要结局
- Compare the cost of the Shang Ring procedure versus conventional surgery(Three months)