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| Name | Class |
|---|---|
| HealthPartners Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard cesarean section surgical technique per surgeon preference | |
| Glove Change | Experimental | Cesarean section including changing of sterile surgical gloves immediately prior to abdominal closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glove change | Procedure | Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 8 weeks following cesarean section |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Scrafford, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard cesarean section surgical technique per surgeon preference |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard cesarean section surgical technique per surgeon preference |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery) | Posted | Count of Participants | Participants | Within 8 weeks following cesarean section |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard cesarean section surgical technique per surgeon preference |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Vogel | University of Minnesota | 6513345982 | isak0023@umn.edu |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 277 |
| 0 |
| 277 |
| EG001 | 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 | 0 | 276 | 0 | 276 |
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