Cesarean Wound Closure in Women With BMI 40 or Greater
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.
- C.Delivery; Penetration, Pregnant Uterus, by Instrument
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- None (Open Label)
|Randomizing to Suture closure of Cesarean Section wound. In woman meeting inclusion criteria and not meeting exclusion criteria.||
|Women in this Arm will be assigned to Standard Surgical Staples closure of Cesarean section. Women will have met inclusion criteria and not meet exclusion criteria and willing to consent to study. Intervention is the randomization to either Arm. Both are standard of care at this facility.||
- NCT ID
- Active, not recruiting
- Mednax Center for Research, Education, Quality and Safety
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.