Cosmetic Results With Tissue Adhesive vs. Subdermal Sutures in Cesarean Section (NCT06760026) | Clinical Trial Compass
CompletedNot Applicable
Cosmetic Results With Tissue Adhesive vs. Subdermal Sutures in Cesarean Section
Honduras36 participantsStarted 2025-01-01
Plain-language summary
Morbidity associated with post-cesarean wound closure, including cosmetically unfavorable scarring, is a significant concern in obstetrics, impacting patient satisfaction and recovery. Recent advances have introduced the use of tissue adhesives, such as 2-octylcyanoacrylate, which promise to improve cosmetic outcomes and reduce postoperative complications. This study will evaluate different tissue adhesive application schedules, keeping the total dose constant, to determine whether the method of application influences cosmetic results and the incidence of postoperative complications
Who can participate
Age range
18 Years – 45 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:
* Submission of a signed and dated informed consent form.
* Declared willingness to comply with all study procedures and availability for the duration of the study.
* Pregnant patient at 37 or more weeks gestation, scheduled for elective cesarean section at the Hospital Materno Infantil.
* Cesarean section performed in the Maternity and Children's Hospital, operating room.
* Literate patient, able to understand and respond to the study questions, with body mass index less than 30.
* Possess cell phone or other means of communication to facilitate postoperative follow-up.
* Residing in the city of Tegucigalpa, Honduras, to ensure accessibility to scheduled follow-up visits.
Exclusion Criteria:
* Patients under 18 years of age.
* Patients with diagnosed psychiatric illnesses that may interfere with their ability to give informed consent or follow the study protocol.
* Pregnant patients with complications that may affect the healing process or increase the risk of postoperative complications, such as severe preeclampsia.
* Diabetes.
* Collagen diseases.
* Autoimmune diseases (rheumatoid arthritis, Crohn's disease).
* Vascular diseases (vasculitis).
* Coagulation disorders (thrombophilia).
* Pregnant patients with premature rupture of membranes, since this may influence the choice of timing and method of cesarean section.
* Pregnant patients diagnosed with chorioamnionitis, which represents an increased risk of postoperative infection.
* Pregnant patients d…
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
1
Changes in the OSAS Scale score
Timeframe: One month from the first intervention until 6 months
Trial details
NCT IDNCT06760026
SponsorRicardo A Gutierrez Ramirez, MD, MSc, FACOG