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临床试验/NCT02907892
NCT02907892已完成不适用

Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:

University of Minnesota2 个研究点 分布在 1 个国家目标入组 554 人开始时间: 2015年7月最近更新:
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
554
试验地点
2
主要终点
Composite Wound Complication

研究概览

简要总结

A randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications

详细描述

This was a randomized, single-blind controlled trial of women who underwent cesarean section at Healthpartners Regions Hospital. Potential participants were identified during routine obstetrical care of singleton pregnancies at Regions Hospital, at the time that cesarean section was decided as the route of delivery by patient and provider. Patients were excluded if the cesarean section was performed emergently. Randomization occurred in the operating room during preparation for cesarean section; nursing staff drew a computer generated allocation card from a stack placed within an envelope in the room. Patients assigned to the control group underwent cesarean section with standard surgical technique at the discretion of the attending surgeon. Patients assigned to the glove change group underwent cesarean section in which the surgical team - surgeon, assistant, and scrub nurse - replaced their outer surgical gloves with a new sterile pair of gloves prior to abdominal closure. Abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section

排除标准

  • Severe immunocompromise (AIDS) or emergent nature of cesarean section

研究组 & 干预措施

Control

No Intervention

Standard cesarean section surgical technique per surgeon preference

Glove Change

Experimental

Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure

干预措施: Glove change (Procedure)

结局指标

主要结局

Composite Wound Complication

时间窗: Within 8 weeks following cesarean section

Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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