Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101, Honduras
NCT Number: NCT06760026
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
Looking for future studies?
Notify Me18 year–45 year
Female
Interventional
Not applicable
Tegucigalpa, Francisco Morazán Department, 11101, Honduras
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: One month from the first intervention until 6 months
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:
Time frame: One month from the first intervention until 6 months
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.
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Other
Cosmetic Results With Tissue Adhesive (2-octylcyanoacrylate) vs. Subdermal Sutures in Cesarean Section: Single-blind Randomized Clinical Trial
Acronym: ADTID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02373501
Cesarean Wound Repair
Ramat Gan, Israel
View Trial DetailsNCT07647458
Tissue Adhesives
Kochi, Kerala, India
View Trial DetailsNCT07547462
Cesarean Section Scar, Wound Healing
Doha, Qatar
View Trial DetailsNCT01697748
Cosmetic Appearance of Cesarean Scar, Infections
Tampa, Florida, United States
View Trial Details