An interventional study of 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision and subdermal suture in Cesarean Wound Repair, Cesarean Section Scar and Cosmetic Appearance of Cesarean Scar, sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG. Completed at 1 site in Honduras. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG · Not applicable, Interventional, and Other
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
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:
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.
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Ricardo A Gutierrez Ramirez, MD, MSc, FACOG is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
wound closure with subdermal sutures using 2-0 nylon thread
Procedure: subdermal suture
2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision
wound closure with subdermal sutures using 2-0 nylon thread, under the same evaluation scheme
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.
Time frame: One month from the first intervention until 6 months
PSAS scale score
The Patient Scar Assessment Scale (PSAS) consists of 6 items on scar-related pain, itching, color, stiffness, thickness, and irregularity. Each item uses a 10-point scoring system, summed to give a total score ranging from 6 to 60, where 6 represents normal skin with no associated symptoms.
Time frame: One month from the first intervention until 6 months
Plan to share: No — It is not necessary, none of the 18 HIPAA identifiers will be placed
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Ricardo A Gutierrez Ramirez, MD, MSc, FACOG