Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Arkansas
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Wound complication rates
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Wound complication rates
Time Frame: 6 weeks postpartum
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). 1. Minor wound disruption: any wound disruption that DOES not require that the incision be opened, evacuated, irrigated or debrided. There is no evidence of infection including erythema, induration or purulent material. No antibiotic therapy is given. 2. Major wound disruption requires that incision be opened, evacuated, and or irrigated or debrided and includes: * Seroma: collection of serous fluid in the wound without evidence of infection * Hematoma: Demonstrable blood clot between the rectus fascia and the skin * Infection: Any wound that drains purulent material and shows at least 2 of the classic signs of infection; induration, erythema, tenderness, fever. Wound infections will be further classified as superficial or deep.
Secondary Outcomes
- Post-operative pain(72 hours postpartum)