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

RecruitingNAAges 18 Years - anyFemaleAsfendiyarov Kazakh National Medical University
NCT07241013 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

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

1 site
Center for Perinatology and Pediatric Surgery (ะฆะŸะธะ”ะšะฅ)
Almaty, Kazakhstan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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