Skin Closure With Tissue Adhesives vs. Subcuticular Suture After Robotic Urogynecologic Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Incision Cosmesis
研究概览
简要总结
To compare skin closure via subcuticular suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis at the 12 week follow up visit. Secondary outcome is the operative time between the two methods of closure.
详细描述
The purpose of this study is compare skin closure via suture versus tissue adhesive (Dermabond) in urogynecological robotic surgeries. The primary outcome is incision cosmesis. Therefore, if the tissue adhesive is cosmetically comparable to that of sutures, that will be reason to use tissue adhesives over traditional sutures. In these surgeries, there are five to six port sites (compared to fewer for usual laparoscopic procedures) and the procedures are lengthy procedures (average duration about 300 minutes as per recent AUGS/ACOG committee opinion), so if the investigators can show significant time reduction for closure, that should reduce operative time and costs. To the investigators' knowledge, this will be the first study of its kind to make this comparison for urogynecologic robotic procedures.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The evaluators of cosmesis will be blind to the group assignment. The person who will evaluate the scars will be a nurse or medical assistant.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, ages 18 years and older, undergoing any urogynecologic robotic procedure at St. John Hospital and Medical Center from March 19, 2018 - November 30, 2018.
排除标准
- •We will exclude women with active skin infections as they may contribute to poor wound healing and infections. We will also exclude procedures that are converted to laparotomy.
研究组 & 干预措施
Tissue Adhesives Only
For the tissue adhesive, we will use Dermabond, which was FDA approved for skin closure in 1998. We will record the length of time of each closure method for comparison, and have patients follow-up at two, six and 12 weeks. At the 12 week visit we will score the appearance of the incision.
干预措施: Tissue Adhesives (Device)
Subcuticular Suture Closure Method Only
For the suture arm we will only close the subcuticular layer. We will record the length of time of each closure method for comparison, and have patients follow-up at two, six and 12 weeks. At the 12 week visit we will score the appearance of the incision.
干预措施: Subcuticular Skin Closure (Procedure)
结局指标
主要结局
Incision Cosmesis
时间窗: 12 weeks
Our primary outcome measure is to compare incision cosmesis between the two closure methods at the 12 week postoperative visit. The Stony Brook Scar Evaluation scale is used. A point is awarded in each of the following categories: width, height, color, hatch/suture marks, overall appearance. Poorer cosmesis is indicated by a lower score. Highest score possible is 5 points.
次要结局
- Incision closure time(30 minutes)
研究者
Sunetris Fluellen
Principal Investigator
St. John Hospital & Medical Center