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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAsfendiyarov Kazakh National Medical University

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

100 Participants
are divided into 2 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