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Low enrollment and Pi had no time.
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This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Skin closure with suture | Active Comparator | Subjects in this group will be randomized to suture for skin closure with computer generated random card draw. |
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| Arm 2: Skin closure with staples | Active Comparator | Subjects randomized to skin closure with staples with computer generated random card draw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture vs. staples closure method after c-section in obese women. | Procedure | Random card draw to either suture skin closure or staple skin closure arm of study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound complication rates | Wound complications will be classified as minor and major and the major complications will be further stratified as Seroma, Hematoma and Wound Infection/Surgical site infection (SSI).
| 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | To allow for adequate monitoring and assessment of postoperative pain, standardized postoperative pain analgesia protocol at our institution will be followed. This comprises of non-steroidal anti- inflammatory drugs and Narcotics as needed. Patients will be asked to complete a visual analog pain scale ranging from 0-10 on postoperative day 2. Information on use of pain medication during hospitalization and frequency will also be collected from the medical record. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary L Racher, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 72 hours postpartum |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |