Comparing tissue adhesive and sutures for cesarean wound closure
Cosmetic Results With Tissue Adhesive (2-octylcyanoacrylate) vs. Subdermal Sutures in Cesarean Section: Single-blind Randomized Clinical Trial
This study is testing whether using a special glue instead of stitches for closing cesarean wounds can make scars look better and help women recover more comfortably after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras Academic / other |
| Locations | 1 site (Tegucigalpa, Francisco Morazán) |
| Trial ID | NCT06760026 on ClinicalTrials.gov |
What this trial studies
This study evaluates the cosmetic outcomes and postoperative complications associated with two methods of wound closure for cesarean sections: tissue adhesive and subdermal sutures. It aims to determine if the application method of a tissue adhesive, specifically 2-octylcyanoacrylate, can improve the aesthetic results of cesarean scars compared to traditional sutures. Conducted in Honduras, the study addresses the importance of both physical and psychological recovery for women undergoing elective cesarean sections. By optimizing wound closure techniques, the research seeks to enhance patient satisfaction and quality of life.
Who should consider this trial
Good fit: Ideal candidates are pregnant women at 37 weeks or more gestation, scheduled for elective cesarean sections, and residing in Tegucigalpa, Honduras.
Not a fit: Patients under 18 years of age or those with psychiatric illnesses or complications affecting healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cosmetic outcomes and higher patient satisfaction for women undergoing cesarean sections.
How similar studies have performed: While the use of tissue adhesives in surgical procedures is gaining attention, this specific comparison in the context of cesarean wound closure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 diagnosed with acute abdomen, which may require emergency surgical management that is not compatible with standard cesarean section procedures. * Pregnant patients with multiple pregnancies, since this could complicate the cesarean section procedure and affect the results of the study. * Presence of major fetal malformations that may require additional interventions at birth. * Fetal stillbirth
Where this trial is running
Tegucigalpa, Francisco Morazán
- Hospital Escuela — Tegucigalpa, Francisco Morazán, Honduras (Recruiting)
Study contacts
- Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: 97546940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.