Trial Outcomes & Findings for Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial (NCT NCT02907892)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

554 participants

Primary outcome timeframe

Within 8 weeks following cesarean section

Results posted on

2018-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Control Standard cesarean section surgical technique per surgeon preference	Glove Change 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 Study STARTED	277	276
Overall Study COMPLETED	250	236
Overall Study NOT COMPLETED	27	40

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Standard cesarean section surgical technique per surgeon preference	Glove Change 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 Study Lost to Follow-up	27	40

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=277 Participants Standard cesarean section surgical technique per surgeon preference	Glove Change n=276 Participants 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 n=553 Participants Total of all reporting groups
Age, Continuous	30.7 Years STANDARD_DEVIATION 5.3 • n=277 Participants	30.6 Years STANDARD_DEVIATION 5.4 • n=276 Participants	30.6 Years STANDARD_DEVIATION 5.3 • n=553 Participants
Sex: Female, Male Female	277 Participants n=277 Participants	276 Participants n=276 Participants	553 Participants n=553 Participants
Sex: Female, Male Male	0 Participants n=277 Participants	0 Participants n=276 Participants	0 Participants n=553 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	277 participants n=277 Participants	276 participants n=276 Participants	553 participants n=553 Participants

PRIMARY outcome

Timeframe: Within 8 weeks following cesarean section

Population: Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery)

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

Outcome measures

Outcome measures
Measure	Control n=250 Participants Standard cesarean section surgical technique per surgeon preference	Glove Change n=236 Participants 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
Composite Wound Complication	34 Participants	15 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glove Change

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Vogel

University of Minnesota

Phone: 6513345982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place