Cesarean Wound RepairADTIDNCT06760026
Cosmetic Results With Tissue Adhesive vs. Subdermal Sutures in Cesarean Section
A study testing 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision and subdermal suture in people with Cesarean Wound Repair and Cesarean Section Scar, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
Trial summary
Morbidity associated with post-cesarean wound closure, including cosmetically unfavorable scarring, is a significant concern in obstetrics, impacting patient satisfaction and recovery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Wound Repair, Cesarean Section Scar, Cosmetic Appearance of Cesarean Scar
- What is being tested?
- 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision and subdermal suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteHonduras
- Study dates
- 1 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Cosmetic Results With Tissue Adhesive (2-octylcyanoacrylate) vs. Subdermal Sutures in Cesarean Section: Single-blind Randomized Clinical Trial
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
Read the 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:
- 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision, subdermal suture
- Keywords
- Cesarean Wound Repair, Cesarean section scar, cosmetic appearance of cesarean scar, tissue adhesives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incisionProcedure or surgery
2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision
subdermal sutureProcedure or surgery
wound closure with subdermal sutures using 2-0 nylon thread, under the same evaluation scheme
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | use 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision Receives: 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 Receives: Procedure: subdermal suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month from the first intervention until 6 months
Secondary outcomes (1)
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.
Measured: One month from the first intervention until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Jul 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Wound RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, parallel-group, randomized clinical trial of superiority
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc, Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760026
- Sponsor's protocol ID
- PGO-UNAH-48-4-2025
- Acronym
- ADTID
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
Publications
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.
PubMed 20417924
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Results With Tissue Adhesive (2-octylcyanoacrylate) vs. Subdermal Sutures in Cesarean Section: Single-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06760026
- Acronym / sponsor ID
- ADTID / PGO-UNAH-48-4-2025
- Conditions
- Cesarean Wound Repair, Cesarean Section Scar, Cosmetic Appearance of Cesarean Scar, Tissue Adhesives
- Keywords
- Cesarean Wound Repair, Cesarean section scar, cosmetic appearance of cesarean scar, tissue adhesives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, parallel-group, randomized clinical trial of superiority
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incisionuse 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision |
| Control | Active comparator | Procedure: subdermal suturewound closure with subdermal sutures using 2-0 nylon thread |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision | Procedure or surgery | Intervention |
| subdermal suturewound closure with subdermal sutures using 2-0 nylon thread, under the same evaluation scheme | Procedure or surgery | Control |
Primary outcome
Changes in the OSAS Scale score
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: * 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.
1 secondary outcome
PSAS scale score
Time frame: One month from the first intervention until 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 20417924Cromi 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.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A. Gutierrez Ramirez, MD, MSc study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-octyl cyanoacrylate tissue adhesive applied continuously over the Pfannenstiel-type cesarean incision and subdermal suture in people with Cesarean Wound Repair and Cesarean Section Scar, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the OSAS Scale score (time frame: One month from the first intervention until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06760026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.