Wound Complications
Conditions
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.
Interventions
PROCEDUREGlove change
Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section
Sponsors
HealthPartners Institute
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Wound Complication | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Standard cesarean section surgical technique per surgeon preference | 277 |
| 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 | 276 |
| Total | 553 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 40 |
Baseline characteristics
| Characteristic | Glove Change | Total | Control |
|---|---|---|---|
| Age, Continuous | 30.6 Years STANDARD_DEVIATION 5.4 | 30.6 Years STANDARD_DEVIATION 5.3 | 30.7 Years STANDARD_DEVIATION 5.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 276 participants | 553 participants | 277 participants |
| Sex: Female, Male Female | 276 Participants | 553 Participants | 277 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 277 | 0 / 276 |
| serious Total, serious adverse events | 0 / 277 | 0 / 276 |
Outcome results
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
Time frame: Within 8 weeks following cesarean section
Population: Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Composite Wound Complication | 34 Participants |
| Glove Change | Composite Wound Complication | 15 Participants |