Is 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures Non-inferior to Continuous Suturing as a Wound Closure Technique in Adult Male Circumcision: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Cosmesis
研究概览
简要总结
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision. The primary objective of this study is to evaluate and compare operative time, pain, cosmesis, complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure. To the best of our knowledge, this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision. The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure. Additionally, this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision.
详细描述
This non-blinded, randomized controlled pilot study is to be conducted at the Men's Health Clinic in Winnipeg, Manitoba. All eligible patients undergoing circumcision will be invited to participate in the study. They will be randomly assigned in a 1:1 ratio using a computer-generated random list. Patients will be randomized to 2-Octyl cyanoacrylate (2-OCA) with four interrupted sutures vs. standard suturing alone. In the post-operative recovery area, patients will be asked to complete a VAS questionnaire. Patients will then be brought in for their routine visit 6 weeks post-op. During the visit, closure of the wound as well as any potential complications will be assessed by a research team member. At that time, a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision. Cosmesis and complications will also be assessed 12 weeks post-op.
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients >16 years of age undergoing circumcision will be included.
排除标准
- •Patients <16 years of age who did not provide consent to be randomized.
结局指标
主要结局
Cosmesis
时间窗: 6 and 12 weeks post-operation
A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation.
Post-operative Pain
时间窗: Immediately post-operation and 6 weeks post-operation
Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient to determine their pain.
Complication Rate
时间窗: 6 and 12 weeks post-operation
Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse.
Intra-Operative Time
时间窗: During the operation
Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished.
次要结局
未报告次要终点
研究者
Premal Patel, MD
Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education
University of Manitoba