Cesarean Skin Incision Trial

Not Applicable

Completed

• Conditions: Wound Complication
• Interventions: Procedure: Pfannenstiel incision; Procedure: vertical skin incision

• Registration Number: NCT01897376
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-12
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

Inclusion Criteria

1. Pregnant women undergoing cesarean delivery for any indication, regardless of number of prior cesarean deliveries
2. Age 18-50 years
3. BMI of 40 kg/m2 or more

Exclusion Criteria

1. Underlying infection such as chorioamnionitis
2. Rupture of membranes over 18 hours prior to cesarean section ,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pfannenstiel incision	Pfannenstiel incision	-
vertical skin incision	vertical skin incision	-

Primary Outcome Measures

Name	Time	Method
composite wound complication	6 weeks post-op	includes surgical site infection as defined by the Centers for Disease Control, as well as seromas, cellulitis, and wound separations

Trial Locations

Locations (2)

UTMB; 🇺🇸 Galveston, Texas, United States

Memorial Hermann Hospital Texas Medical Center; 🇺🇸 Houston, Texas, United States