Cesarean Skin Incision Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine if there is a difference between Pfannenstiel and midline vertical skin incision at time of cesarean section in preventing wound complications in the morbidly obese patient. This is a comparative effectiveness study of two commonly-used skin incisions. The investigators plan to enroll morbidly obese obstetrical patients upon admission and randomize them to one of the above incision types in the operating room. The investigators will follow them for 6 weeks post-op to evaluate for wound complications. There is minimal risk to the participant as both incision types are acceptable in current obstetrical practice. There is no direct benefit to the patient. Currently, there is no level I evidence to support either Pfannenstiel or midline vertical skin incision in the prevention of wound complications in the obese patient undergoing cesarean section. Therefore, current practice is for the surgeon to make the decision based on preference and weighing theoretic risks. Therefore, there is clinical equipoise. Cesarean section is a very common procedure, with a national rate of 32% of all live births in 2007. Not only does obesity increase the expectant mother's risk of a cesarean section, it is also a well recognized risk factor for wound complication. The cesarean wound complication rate in the morbidly obese population at the University Of Texas at Houston - Memorial Hermann Hospital Texas Medical Center in 2011 was roughly twenty times as high as the normal weight population, 28% compared to 1.4%. Results from this study could be extrapolated in the future to affect lower post-operative morbidity, higher patient satisfaction, less antibiotic use, shorter hospital stay, and overall lower health care costs.

Official Title
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The Comparative Effectiveness of Pfannenstiel Versus Vertical Skin Incision in Preventing Wound Complications After Cesarean Delivery in Morbidly Obese Women: a Randomized Clinical Trial.

Conditions
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Wound Complication

Intervention / Treatment
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* Procedure: Pfannenstiel incision
* Procedure: vertical skin incision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries Age 18-50 years BMI of 40 kg/m2 or more Exclusion Criteria: Underlying infection such as chorioamnionitis Rupture of membranes over 18 hours prior to cesarean section ,

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pfannenstiel incision<br> | Procedure: Pfannenstiel incision<br>* Pfannenstiel incision at time of cesarean section<br>|
| Other: vertical skin incision<br> | Procedure: vertical skin incision<br>* vertical skin incision at time of cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite wound complication | includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations | 6 weeks post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound, infection, cesarean delivery, obesity