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临床试验/NCT02332252
NCT02332252已完成不适用

Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.

Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年8月1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
发起方
入组人数
500
试验地点
1
主要终点
Surgical Site Infection

研究概览

简要总结

To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.

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

性别
Female
接受健康志愿者

入选标准

  • Elective Cesarean section, regardless of gestational age.

排除标准

  • Skin infection in the cesarean section area.
  • Emergency cesarean section.
  • Presence of a maternal pathology that increases the risk of infection (immunocompromised state).

研究组 & 干预措施

Scalpel

Active Comparator

Skin incision performed with a scalpel during cesarean section.

干预措施: Skin incision (Procedure)

Scalpel

Active Comparator

Skin incision performed with a scalpel during cesarean section.

干预措施: Scalpel (Device)

Electrocautery

Experimental

Skin incision performed with an electrocautery during cesarean section.

干预措施: Electrocautery (Device)

Electrocautery

Experimental

Skin incision performed with an electrocautery during cesarean section.

干预措施: Skin incision (Procedure)

结局指标

主要结局

Surgical Site Infection

时间窗: 8 days

Presence of signs of surgical site infection after cesarean section.

次要结局

  • Post operative pain(8 days)

研究者

发起方
Saint Thomas Hospital, Panama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Osvaldo A. Reyes T.

Coordinator of research

Saint Thomas Hospital, Panama

研究点 (1)

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