NCT02685761

Skin Incisions and Wound Complication Rates for C-sections in Obese Women

Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.

Conditions

• Obesity
• Infection; Cesarean Section
• Surgical Wound

Interventions

Type	Name	Description
PROCEDURE	Midline Vertical	Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis
PROCEDURE	High Transverse	Cesarean section performed using a transverse skin incision located above the pannus

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2016-02-19
• Last updated: 2016-09-13

Locations

7 sites across 1 country: United States