Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial
Primary Purpose
Wound Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glove change
Sponsored by
About this trial
This is an interventional other trial for Wound Complications
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
Sites / Locations
- Regions Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Glove Change
Arm Description
Standard cesarean section surgical technique per surgeon preference
Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02907892
First Posted
September 16, 2016
Last Updated
December 8, 2017
Sponsor
University of Minnesota
Collaborators
HealthPartners Institute
1. Study Identification
Unique Protocol Identification Number
NCT02907892
Brief Title
Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial
Official Title
Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
HealthPartners Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Complications
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
554 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard cesarean section surgical technique per surgeon preference
Arm Title
Glove Change
Arm Type
Experimental
Arm Description
Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure
Intervention Type
Procedure
Intervention Name(s)
Glove change
Intervention Description
Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section
Primary Outcome Measure Information:
Title
Composite Wound Complication
Description
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
Time Frame
Within 8 weeks following cesarean section
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Scrafford, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial
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