Tissue-Engineered Construct Based on Amniotic Membrane and Calcium Alginate for Cesarean Section Wound Healing
NCT07241013 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-11-21
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.
Conditions
- Skin Wound Healing After Cesarean Section
- Cesarean Section Scar Healing
Interventions
- DEVICE
-
Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
Application 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.
Sponsors & Collaborators
-
Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan
collaborator UNKNOWN -
Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan
collaborator UNKNOWN -
Asfendiyarov Kazakh National Medical University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-30
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- Kazakhstan
Study Locations
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