CompletedNot Applicable

Cesarean Wound Closure in Women With BMI 40 or Greater

United States232 participantsStarted 2015-09

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of wound complication, comparing the outcomes from the two arms

Timeframe: 2 years

Trial details

NCT IDNCT02549131

SponsorPediatrix

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03

View on ClinicalTrials.gov More C.Delivery; Penetration, Pregnant Uterus, by Instrument trials