Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:
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
- 是
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
Standard cesarean section surgical technique per surgeon preference
Glove Change
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
