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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02685761
• Other study ID #: 4128
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2016
• Last updated: September 12, 2016
• Start date: September 2015
• Est. completion date: September 2021

Study information

• Verified date: September 2016
• Source: Albany Medical College
• Contact: Peter R Cole, MD
• Phone: 518-262-4942
• Email: colep[@]mail.amc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 309
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pre-pregnancy BMI equal or greater than 40

Exclusion Criteria:

• prior cesarean section or laparotomy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection; Cesarean Section
• Obesity
• Surgical Wound
• Wounds and Injuries

Intervention

Procedure:
• Midline Vertical
Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis
• High Transverse
Cesarean section performed using a transverse skin incision located above the pannus

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Albany Medical Center Obstetrics and Gynecology	Albany	New York
United States	Albany Medical Center Obstetrics and Gynecology	Albany	New York
United States	Albany Medical Center Obstetrics and Gynecology	Ballston Spa	New York
United States	Albany Medical Center Obstetrics and Gynecology	Clifton Park	New York
United States	Albany Medical Center Obstetrics and Gynecology	Delmar	New York
United States	Albany Medical Center Obstetrics and Gynecology	Latham	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Complications		6 months	Yes