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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02907892
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
HealthPartners Institute
Information provided by (Responsible Party):
University of Minnesota

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

Condition or disease Intervention/treatment Phase
Wound Complications Procedure: Glove change Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:
Study Start Date : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Standard cesarean section surgical technique per surgeon preference
Experimental: Glove Change
Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure
Procedure: Glove change
Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section




Primary Outcome Measures :
  1. Composite Wound Complication [ Time Frame: Within 8 weeks following cesarean section ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907892


Locations
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United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
University of Minnesota
HealthPartners Institute
Investigators
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Principal Investigator: Jonathan Scrafford, MD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02907892    
Other Study ID Numbers: 1416
First Posted: September 20, 2016    Key Record Dates
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes