An interventional study of Glove change in Wound Complications, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.
Sponsored by University of Minnesota · Not applicable, Interventional, and Other
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
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.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 554 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard cesarean section surgical technique per surgeon preference
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
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
| Milestone | Control | Glove Change |
|---|---|---|
| Started | 277 | 276 |
| Completed | 250 | 236 |
| Not completed | 27 | 40 |
| Withdrew: Lost to follow-up | 27 | 40 |
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
| Participants | Control | Glove Change |
|---|---|---|
| Composite Wound Complication | 34 | 15 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/277 (0%) | 0/277 (0%) |
| Glove Change | — | 0/276 (0%) | 0/276 (0%) |
| Age, Continuous(Years) | Control | Glove Change | Total |
|---|---|---|---|
| Mean | 30.7 ± 5.3 | 30.6 ± 5.4 | 30.6 ± 5.3 |
| Sex: Female, Male(Participants) | Control | Glove Change | Total |
|---|---|---|---|
| Female | 277 | 276 | 553 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Control | Glove Change | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Control | Glove Change | Total |
|---|---|---|---|
| United States | 277 | 276 | 553 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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University of Minnesota