Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pediatrix
- Enrollment
- 232
- Locations
- 4
- Primary Endpoint
- Rate of wound complication, comparing the outcomes from the two arms
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant woman
- •Time to approach and consent the patient prior to undergoing cesarean delivery
- •Able to give informed consent, include age 18 or greater and ability to read and understand English
- •BMI of 40 or greater on most recent hospital documentation
- •Willingness to participate in the study and ability to read, understand and sign the informed consent document
Exclusion Criteria
- •Inability to give informed consent, including inability to read and understand English and age under 18 years
- •Evidence of current skin infection or breakdown at or near the site of surgical incision
- •Any immune compromised status, including AIDS
- •Negative pressure wound therapy applied at time of surgery
Outcomes
Primary Outcomes
Rate of wound complication, comparing the outcomes from the two arms
Time Frame: 2 years
Rate of wound complication comparing the outcomes of subcuticular sutures to surgical staples for cesarean wound closure in the obese gravida during the first 6 weeks postpartum.
Secondary Outcomes
- Type and location of cesarean incisions in the obese gravida.(2 years)
- Effect of medical comorbidities on wound disruption.(2 years)
- Frequency of and risk factors for wound complication after cesarean delivery in the obese gravida.(2 years)