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临床试验/NCT02838017
NCT02838017终止不适用

Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial

NorthShore University HealthSystem6 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
504
试验地点
6
主要终点
Number of Participants With Wound Complication

研究概览

简要总结

The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women undergoing Pfannenstiel Cesarean delivery

排除标准

  • Inability to provide informed consent in English
  • Planned use of staples for skin closure
  • Unavailability of research personnel to accomplish consent and randomization at the time of cesarean

研究组 & 干预措施

Tissue Adhesive

Experimental

Tissue Adhesive will be placed over subcuticular suture closure.

干预措施: Tissue Adhesive (Device)

Steri-Strips

Active Comparator

Sterile strips will be placed over subcuticular suture closure.

干预措施: Sterile strips (Device)

结局指标

主要结局

Number of Participants With Wound Complication

时间窗: 6-8 weeks from cesarean delivery

Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation

次要结局

  • Number of Participants With Readmission for Wound Complication(Within 8 weeks from cesarean delivery)
  • Satisfaction With Cesarean Scar(6-8 weeks from cesarean delivery)
  • Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication(Within 8 weeks of delivery)
  • Operative Time(At time of delivery)
  • Number of Participants Requiring Antibiotic Treatment for Wound Complication(Within 8 weeks of delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Plunkett

Clinical Associate Professor, Maternal & Fetal Medicine, Obstetrics & Gynecology

NorthShore University HealthSystem

研究点 (6)

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