Tissue-Engineered Construct Based on Amniotic Membrane and Calcium Alginate for Cesarean Section Wound Healing

November 16, 2025 updated by: Gulzhan Muratovna Issina, Asfendiyarov Kazakh National Medical University

Development of an Innovative Method for Producing a Biodegradable Tissue-Engineered Construct From Amniotic Membrane for the Epithelialization of Postoperative Wounds

This clinical trial aims to evaluate the safety and efficacy of an experimental tissue-engineered construct (TEC) based on amniotic membrane and calcium alginate for promoting epithelialization and improving scar quality in patients after cesarean section. The study will assess both biological and clinical indicators of wound healing, including cytokine dynamics (IL-6, IL-10), ultrasound characteristics, and patient-reported outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The amniotic membrane (AM) is a natural biological material with regenerative and anti-inflammatory properties. In this study, a biodegradable tissue-engineered construct (TEC) combining amniotic membrane and calcium alginate is applied to the postoperative wound after cesarean section.

A total of 100 participants will be randomized into two groups:

  1. Experimental group - TEC application to the postoperative wound.
  2. Control group - standard postoperative wound care without TEC. Outcomes will include objective ultrasound measures of scar formation, cytokine profile changes, clinical scar evaluation (POSAS), and cosmetic appearance at 12 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan
        • Recruiting
        • Center for Perinatology and Pediatric Surgery (ЦПиДКХ)
        • Contact:
          • Issenova S.Sh. Professor, Head of the Department of Obstetrics and Gynecology
          • Phone Number: +77051727500
          • Email: isenova.s@kaznmu.kz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women aged 18 years and older.
  2. Planned elective cesarean section for medical indications (breech presentation, multiple pregnancy, large fetus, uterine scar, etc.).
  3. Absence of severe obstetric complications (e.g., preeclampsia, hemorrhage, placental abruption).
  4. No decompensated chronic diseases or acute infections.
  5. Signed written informed consent.

Exclusion Criteria:

  1. Acute infectious, autoimmune, or oncological diseases.
  2. Severe pregnancy complications (preeclampsia, eclampsia, decompensated gestational diabetes).
  3. Emergency cesarean section.
  4. Severe postpartum complications: massive bleeding (>1000 mL), infection, abscess, severe anemia, allergic reactions to dressing materials.
  5. Withdrawal of consent or inability to continue participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate)
Application of the bioengineered tissue construct (amniotic membrane and calcium alginate) on the postoperative skin incision after cesarean section.
Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
Application of a bioresorbable tissue-engineered construct (based on amniotic membrane and calcium alginate) on the postoperative skin incision site to promote epithelialization and improve scar healing.
No Intervention: Standard Postoperative Care
Routine postoperative wound care after cesarean section without tissue-engineered construct application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration
Time Frame: Preoperative baseline, Day 3, Day 28
Dynamic evaluation of systemic inflammatory response; IL-6, 10 levels measured by ELISA in peripheral blood.
Preoperative baseline, Day 3, Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
POSAS clinical scar assessment (Observer and Patient Scale)
Time Frame: Day 5-7, Day 28
Clinical evaluation of scar healing using the Patient and Observer Scar Assessment Scale (POSAS), including vascularity, pigmentation, thickness, relief, and pliability. Both patient and clinician assessments collected.
Day 5-7, Day 28
Ultrasound-assessed scar thickness and echogenicity
Time Frame: Day 3, Day 28
Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging.
Day 3, Day 28
Cosmetic and photographic scar assessment
Time Frame: Week 12
Remote follow-up with voluntary photographic documentation and patient self-assessment of cosmetic outcomes (color, relief, discomfort, satisfaction).
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asfendiyarov Kazakh National Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan
Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TEC-CS-2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data (IPD) will not be shared because the study involves a limited number of participants and includes sensitive personal and clinical data. Data will be used only within the study team for scientific analysis and publication in aggregated form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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