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.
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.
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.
Parallel
Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
DeviceApplication 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.
Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration
Dynamic evaluation of systemic inflammatory response; IL-6, 10 levels measured by ELISA in peripheral blood.
POSAS clinical scar assessment (Observer and Patient Scale)
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.
Ultrasound-assessed scar thickness and echogenicity
Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging.
Cosmetic and photographic scar assessment
Remote follow-up with voluntary photographic documentation and patient self-assessment of cosmetic outcomes (color, relief, discomfort, satisfaction).
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Asfendiyarov Kazakh National Medical University
Lead sponsor
Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan
Collaborator
Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan
Collaborator
