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

Wound Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907892
• Other study ID #: 1416
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: December 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Wound Complications

Intervention

Procedure:
• Glove change
Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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