Cesarean Wound Closure in Women With BMI 40 or Greater
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 3/16/2019 |
| Start Date: | September 2015 |
| End Date: | February 2020 |
| Contact: | Ana Bodea Braescu, MSN, MPH |
| Phone: | 480-969-5999 |
Cesarean Wound Closure in Women With BMI 40 or Greater: A Randomized Controlled Trial Comparing Subcuticular Suture to Surgical Staples
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
