Obesity, Pregnancy
Conditions
Keywords
cesarean delivery, wound complications, skin closure methods
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.
Interventions
PROCEDURESuture vs. staples closure method after c-section in obese women.
Random card draw to either suture skin closure or staple skin closure arm of study.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * BMI ≥ 30kg/m2 on admission to labor and delivery * Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery * Singleton pregnancies * Gestational age ≥ 24weeks * Cesarean delivery performed under regional anesthesia
Exclusion criteria
* Refusal to participate * BMI \< 30kg/m2 * \< 24 weeks gestation * Intrauterine fetal demise * Chronic pain syndrome requiring chronic narcotic use * Emergent clinical situations which preclude obtaining informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound complication rates | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 72 hours postpartum | 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. |
Countries
United States
Outcome results
None listed