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临床试验/NCT03120806
NCT03120806已完成不适用

Comparative Study Between Interrupted and Continuous Subcuticular Skin Suturing in Women Undergoing Elective Cesarean Section. A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2017年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
1
主要终点
wound infection

研究概览

简要总结

Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material

详细描述

Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.

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
19 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •18 years or older
  • •Overall good health
  • •Elective Cesarean section ASA class 1 or 2

排除标准

  • •Allergy to synthetic suture materials
  • •Diabetes whether gestational or pregestational
  • •use of steroid or immunosuppresive medication within last 6 month of procedure
  • •Skin sepsis or systemic fever
  • •BMI > 35
  • •History of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing ASA class 3 or 4

研究组 & 干预措施

continous subcuticular

Active Comparator

skin closed with continous subcuticular mattress suture using non-absorbable polypropylene

干预措施: continuous subcuticular skin closure (Procedure)

Interrupted subcuticular

Active Comparator

skin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene

干预措施: Interrupted subcuticular skin closure (Procedure)

结局指标

主要结局

wound infection

时间窗: 10 days after surgery

occurrence of signs of wound infection

次要结局

  • postoperative pain(12 hours after surgery)
  • wound hematoma(10 days after surgery)
  • scar dehiscence(10 days after surgery)
  • wound seroma(10 days after surgery)
  • the need for reclosure(10 days after surgery)

研究者

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

Ahmed M Maged, MD

Professor

Cairo University

研究点 (1)

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