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NCT Number: NCT07241013

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Perinatology and Pediatric Surgery (ЦПиДКХ)

Almaty, Kazakhstan

Location status: Recruiting

Location contact

Issenova S.Sh. Professor, Head of the Department of Obstetrics and Gynecology

CONTACT

[email protected]

+77051727500

About this study

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:

  • Experimental group - TEC application to the postoperative wound.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Asfendiyarov Kazakh National Medical University

Other

Collaborators

  • Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan
  • Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

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.