NCT02907892

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Wound Complications

Interventions

Type	Name	Description
PROCEDURE	Glove change	Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2016-09-20
• Last updated: 2018-08-17
• Results posted: 2018-08-17

Locations

1 site across 1 country: United States