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

University of Minnesota (UMN)

Status: Completed

Conditions: Wound Complications

Treatments: Procedure: Glove change

Study type: Interventional

Funder types: Other

Identifiers

NCT02907892

1416

Details and patient eligibility

About

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

Full 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.

Enrollment: 554 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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554 participants in 2 patient groups

Control

No Intervention group

Description:

Standard cesarean section surgical technique per surgeon preference

Glove Change

Experimental group

Description:

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

Treatment:

Procedure: Glove change