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

NCT ID: NCT02907892

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-01-31

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.

Conditions

Wound Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control

Standard cesarean section surgical technique per surgeon preference

Group Type: NO_INTERVENTION

No interventions assigned to this group

Glove Change

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

Group Type: EXPERIMENTAL

Glove change

Intervention Type: PROCEDURE

Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section

Interventions

Glove change

Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Scrafford, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

1416

Identifier Type: -

Identifier Source: org_study_id