RecruitingNot Applicable

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

Kazakhstan100 participantsStarted 2025-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration

Timeframe: Preoperative baseline, Day 3, Day 28

Trial details

NCT IDNCT07241013

SponsorAsfendiyarov Kazakh National Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Skin Wound Healing After Cesarean Section trials