Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial
- Conditions
- Wound Complications
- Interventions
- Procedure: Glove change
- Registration Number
- NCT02907892
- Lead Sponsor
- University of Minnesota
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 554
- Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section
- Severe immunocompromise (AIDS) or emergent nature of cesarean section
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glove Change Glove change Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure
- Primary Outcome Measures
Name Time Method Composite Wound Complication 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States