Comparing Tissue Adhesives in Port Site Closure: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- proportion of patients who develop contact dermatitis
研究概览
简要总结
This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.
详细描述
Study Design
This is a multi-center randomized controlled trial to evaluate two different methods of reinforcing surgical port site closure: 2-Octylcyanoacrylate and n-butyl-2-cyanoacrylate.
Methods
Inclusion Criteria All adult patients undergoing an elective laparoscopic or robotic abdominal surgery with the Minimally Invasive Surgeons of Texas (MIST) either at Texas Medical Center or Sugar Land will be eligible.
Exclusion criteria
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor does not know which glue was used
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or older
- •undergoing an elective laparoscopic or robotic abdominal surgery
排除标准
- •Patients unlikely to follow-up (live out of state, unable to be reached by phone or email)
- •Patients with a known allergy to 2-Octylcyanoacrylate or N-butyl-2-cyanoacrylate.
研究组 & 干预措施
Dermabond (2-Octylcyanoacrylate)
Dermabond over incisions
干预措施: Dermabond (2-Octylcyanoacrylate) (Device)
Swiftset (N-butyl-2-cyanoacrylate)
Swiftset over incisions
干预措施: Swiftset (N-butyl-2-cyanoacrylate) (Device)
Liquiband (2-Octylcyanoacrylate)
Liquiband over incisions
干预措施: Liquiband (2-Octylcyanoacrylate) (Device)
结局指标
主要结局
proportion of patients who develop contact dermatitis
时间窗: 6 weeks
erythema or rash around incisions
次要结局
- proportion of patients with surgical site infection(6 weeks)
- mean diameter of erythema(6 weeks)
- proportion of patients with wound dehiscence(6 weeks)
研究者
Julie Holihan
Assistant Professor of Surgery
The University of Texas Health Science Center, Houston