Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07241013

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

Led by Asfendiyarov Kazakh National Medical University · Updated on 2025-11-21

100

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

Sponsors

A

Asfendiyarov Kazakh National Medical University

Lead Sponsor

C

Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years and older
  • Planned elective cesarean section for medical indications (e.g., breech presentation, multiple pregnancy, large fetus, uterine scar)
  • No severe obstetric complications such as preeclampsia, hemorrhage, or placental abruption
  • No decompensated chronic diseases or acute infections
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Acute infectious, autoimmune, or cancerous diseases
  • Severe pregnancy complications including preeclampsia, eclampsia, or decompensated gestational diabetes
  • Emergency cesarean section
  • Severe postpartum complications like massive bleeding over 1000 mL, infection, abscess, severe anemia, or allergic reaction to dressing materials
  • Withdrawal of consent or inability to continue participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for Perinatology and Pediatric Surgery (ЦПиДКХ)

Almaty, Kazakhstan

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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