Sutures vs. Staples Skin Closure After C-section in Obese Patients

Study Overview
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Brief Summary
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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.

Official Title
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Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients

Conditions
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Obesity, Pregnancy

Intervention / Treatment
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* Procedure: Suture vs. staples closure method after c-section in obese women.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Skin closure with suture<br>Subjects in this group will be randomized to suture for skin closure with computer generated random card draw. | Procedure: Suture vs. staples closure method after c-section in obese women.<br>* Random card draw to either suture skin closure or staple skin closure arm of study.<br>|
| Active Comparator: Arm 2: Skin closure with staples<br>Subjects randomized to skin closure with staples with computer generated random card draw. | Procedure: Suture vs. staples closure method after c-section in obese women.<br>* Random card draw to either suture skin closure or staple skin closure arm of study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). 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. 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. | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | 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. | 72 hours postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean delivery, wound complications, skin closure methods