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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Wound Complications
Intervention Procedure: Glove change
Enrollment 554
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Glove Change
Hide Arm/Group Description Standard cesarean section surgical technique per surgeon preference

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

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

Period Title: Overall Study
Started 277 276
Completed 250 236
Not Completed 27 40
Reason Not Completed
Lost to Follow-up             27             40
Arm/Group Title Control Glove Change Total
Hide Arm/Group Description Standard cesarean section surgical technique per surgeon preference

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

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

Total of all reporting groups
Overall Number of Baseline Participants 277 276 553
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 277 participants 276 participants 553 participants
30.7  (5.3) 30.6  (5.4) 30.6  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 276 participants 553 participants
Female
277
 100.0%
276
 100.0%
553
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 277 participants 276 participants 553 participants
277 276 553
1.Primary Outcome
Title Composite Wound Complication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery)
Arm/Group Title Control Glove Change
Hide Arm/Group Description:
Standard cesarean section surgical technique per surgeon preference

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

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

Overall Number of Participants Analyzed 250 236
Measure Type: Count of Participants
Unit of Measure: Participants
34
  13.6%
15
   6.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Glove Change
Hide Arm/Group Description Standard cesarean section surgical technique per surgeon preference

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

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

All-Cause Mortality
Control Glove Change
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Glove Change
Affected / at Risk (%) Affected / at Risk (%)
Total   0/277 (0.00%)   0/276 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Glove Change
Affected / at Risk (%) Affected / at Risk (%)
Total   0/277 (0.00%)   0/276 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rachel Vogel
Organization: University of Minnesota
Phone: 6513345982
EMail: isak0023@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02907892     History of Changes
Other Study ID Numbers: 1416
First Submitted: September 16, 2016
First Posted: September 20, 2016
Results First Submitted: December 8, 2017
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018