NCT06760026

Cosmetic Results With Tissue Adhesive vs. Subdermal Sutures in Cesarean Section

Cosmetic Results With Tissue Adhesive (2-octylcyanoacrylate) vs. Subdermal Sutures in Cesarean Section: Single-blind Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

In Honduras, as in many parts of the world, cesarean section is a common obstetric practice. The choice of wound closure method in this procedure has significant implications not only in terms of the patient's physical health, but also in her psychological and aesthetic well-being. The scar resulting from a cesarean section can have a lasting impact on a woman's perception of her own body, affecting her self-esteem and quality of life. Historically, in Honduras, the use of subdermal sutures with nylon thread has been preferred for the closure of post-cesarean section wounds. However, with advances in medical technology, tissue adhesives have emerged as a promising alternative, potentially offering a better cosmetic outcome, faster application, and more comfortable recovery for the patient. This study is crucial in the Honduran context for several reasons: 1. improved Cosmetic Outcomes and Patient Satisfaction: By comparing two methods of wound closure, this study seeks to identify the technique that offers better cosmetic results, which could significantly improve the satisfaction and psychological well-being of patients undergoing elective cesarean sections. 2. Adaptation to Local Resources: In a country like Honduras, where health resources may be limited, it is essential to optimize the use of technologies and surgical materials. This study will provide valuable information on the feasibility and efficacy of tissue adhesives compared to the traditional method, taking into account factors such as cost and availability of materials. 3. Reduction of Postoperative Complications: By evaluating and comparing the incidence of complications associated with each closure method, the study could contribute to improve surgical practices and reduce the incidence of postoperative complications, which is of great relevance in the context of public health in Honduras. 4. Impact on Resource Management in the Health System: In the context of a country with possibly limited health resources such as Honduras, it is essential to evaluate not only the clinical efficacy of surgical techniques, but also their cost-effectiveness. This study will provide information on the relative costs of the use of tissue adhesives compared to subdermal sutures, which is relevant for planning and resource allocation in the health system. 5. Fostering Research and Evidence-Based Medicine in Honduras: This study will contribute to the growing need for contextualized medical research in Honduras, promoting the practice of evidence-based medicine that takes into account local realities and the specific needs of the population. Objective: To evaluate the effects on morbidity and postoperative cosmetic outcomes of the use of tissue adhesive versus subdermal sutures in Pfannenstiel-type cesarean sections.

Conditions

• Cesarean Wound Repair
• Cesarean Section Scar
• Cosmetic Appearance of Cesarean Scar
• Tissue Adhesives

Interventions

Type	Name	Description
PROCEDURE	2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision	2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision
PROCEDURE	subdermal suture	wound closure with subdermal sutures using 2-0 nylon thread, under the same evaluation scheme

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-07-31
• Completion: 2025-12-30
• First posted: 2025-01-06
• Last updated: 2026-02-17

Locations

1 site across 1 country: Honduras