Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | use 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| One month from the first intervention until 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month from the first intervention until 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ricardo A. Gutierrez Ramirez, MD, MSc | Universidad Nacional Autonoma de Honduras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Escuela | Tegucigalpa | Francisco Morazán Department | 11101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20417924 | Background | 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. |
Not provided
Not provided
It is not necessary, none of the 18 HIPAA identifiers will be placed
Not provided
Not provided
Not provided
Not provided
Not provided
Single-blind, parallel-group, randomized clinical trial of superiority
Not provided
Not provided
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.
| subdermal suture | Procedure | wound closure with subdermal sutures using 2-0 nylon thread, under the same evaluation scheme |
|