NCT02549131

Cesarean Wound Closure in Women With BMI 40 or Greater

Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Pediatrix · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized controlled prospective trial is to guide physicians on the most effective evidenced based skin closure during a cesarean section for the obese gravida, defined as a BMI of 40 or greater. The study will compare two closure methods: subcuticular sutures and surgical staples.

Detailed description

The study will screen and attempt to enroll pregnant women admitted to labor and delivery who have a BMI of 40 or greater. The participants will be randomized to receiving skin closure with subcuticular sutures or surgical staples if they undergo cesarean section. Either technique is currently standard of care. Participants who end up undergoing cesarean section will be included in the final data analysis. The participants will be followed for wound complication in the first 6 weeks post operatively. Wound complication will be defined as wound disruption or infection within 6 weeks post operatively. Design and Project Type This study is a randomized controlled trial. At the study facility, in 2012 and 2013, over 300 cesarean sections were performed each year in women with BMI of 40 or greater. Based on this, the investigators expect the duration of the study to be 2 years. Randomization and data collection will be completed on 420 women. Description of Intervention Two interventions will be used in this project: subcuticular suture and surgical staples. The subcuticular suture will be the size and type of suture chosen by the surgeon at the time of cesarean. The surgical staples will be the standard staples used on the labor and delivery unit.

Conditions

• C.Delivery; Penetration, Pregnant Uterus, by Instrument
• Obesity

Interventions

Type	Name	Description
PROCEDURE	Randomizing to Suture or Staple closure of Cesarean section	Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-03-01
• Completion: 2021-01-01
• First posted: 2015-09-15
• Last updated: 2022-08-26

Locations

2 sites across 1 country: United States