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 range18 Years – 45 Years

SexFEMALE

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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…

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31