About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
Treatment groups
Sponsors and collaborators
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