Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound Complications

Intervention / Treatment
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* Procedure: Glove change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section Exclusion Criteria: Severe immunocompromise (AIDS) or emergent nature of cesarean section
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard cesarean section surgical technique per surgeon preference | |
| Experimental: Glove Change<br>Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure | Procedure: Glove change<br>* Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Wound Complication | 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 | Within 8 weeks following cesarean section |