CompletedNot Applicable

A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study

United States151 participantsStarted 2023-08-23

Plain-language summary

The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

Who can participate

Age range

18 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: * Women age 18 years or older * All women scheduled for primary or repeat cesarean deliveries * All women undergoing intrapartum or antepartum cesarean delivery * Pfannenstiel skin incision * Birth of a live infant at time of cesarean delivery Exclusion Criteria: * Vertical skin incision * Cesarean hysterectomy * Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc) * Intrapartum stillbirth * Planned postpartum follow up at another facility * Contraindications to routine postpartum pain medications * Adhesive or tape allergy

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

Patient Scar Satisfaction Scale Score

Timeframe: Assessed at 6-weeks postpartum

Trial details

NCT IDNCT05903547

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-06

Results submitted2025-12-05

View on ClinicalTrials.gov More Cesarean Section trials