RecruitingNot ApplicableNCT07241013

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

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

Sponsor

Asfendiyarov Kazakh National Medical University

Enrollment

100 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Skin Wound Healing After Cesarean Section Cesarean Section Scar Healing

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria5

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.

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Interventions

DEVICETissue-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.

Locations(1)

Center for Perinatology and Pediatric Surgery (ЦПиДКХ)

Almaty, Kazakhstan

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NCT07241013