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

NCT06760026 | Completed DMC

• 1 other identifier: PGO-UNAH-48-4-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

Cesarean Wound Repair; Cesarean section scar; cosmetic appearance of cesarean scar; tissue adhesives

Outcome Measures

Primary Outcomes (1)

• Changes in the OSAS Scale score

  The OSAS score is based on the assessment of several aspects of a scar, and each of these aspects is scored individually. Each variable uses a 10-point scoring system, where 1 represents normal foot. The scores of the individual variables can be added together to obtain a total score ranging from 5 to 50, where 5 represents normal skin. Items typically assessed include: * Vascularity: Refers to the presence of visible blood vessels or red coloration in the scar. * Pigmentation: Assesses whether the scar has a different color than the surrounding skin. * Thickness: Refers to the height or prominence of the scar above the level of the surrounding skin. * Relief: Assesses the texture of the scar compared to the surrounding skin. * Flexibility: Measures how stiff or flexible the scar is compared to the surrounding skin.

  One month from the first intervention until 6 months

Secondary Outcomes (1)

• PSAS scale score

  One month from the first intervention until 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

use 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision

Procedure: 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision

Control

ACTIVE COMPARATOR

wound closure with subdermal sutures using 2-0 nylon thread

Procedure: subdermal suture

Interventions

2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision PROCEDURE

2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision

Intervention

subdermal suture PROCEDURE

wound closure with subdermal sutures using 2-0 nylon thread, under the same evaluation scheme

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.

  PMID: 20417924 BACKGROUND

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the patient and the principal investigator will know the intervention, the data analyst researcher does not know the group to which the patients have been assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Titular professor

Model Details: Single-blind, parallel-group, randomized clinical trial of superiority

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: December 30, 2025
• Last Updated: February 17, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)