Tissue-Engineered Construct Based on Amniotic Membrane and Calcium Alginate for Cesarean Section Wound Healing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC).
- Who it may be relevant to
- Registry conditions: Skin Wound Healing After Cesarean Section, Cesarean Section Scar Healing. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kazakhstan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of an Innovative Method for Producing a Biodegradable Tissue-Engineered Construct From Amniotic Membrane for the Epithelialization of Postoperative Wounds
Overview
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.
Detailed description
The amniotic membrane (AM) is a natural biological material with regenerative and anti-inflammatory properties. In this study, a biodegradable tissue-engineered construct (TEC) combining amniotic membrane and calcium alginate is applied to the postoperative wound after cesarean section.
A total of 100 participants will be randomized into two groups:
1. Experimental group - TEC application to the postoperative wound. 2. Control group - standard postoperative wound care without TEC. Outcomes will include objective ultrasound measures of scar formation, cytokine profile changes, clinical scar evaluation (POSAS), and cosmetic appearance at 12 weeks.
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.
Primary outcome measures
- Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration [Time frame: Preoperative baseline, Day 3, Day 28]
Secondary outcome measures (3)
- POSAS clinical scar assessment (Observer and Patient Scale) [Time frame: Day 5-7, Day 28]
- Ultrasound-assessed scar thickness and echogenicity [Time frame: Day 3, Day 28]
- Cosmetic and photographic scar assessment [Time frame: Week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kazakhstan · 1 center
- Center for Perinatology and Pediatric Surgery (ЦПиДКХ) — Almaty
Identifiers
NCT: NCT07241013 · TEC-CS-2025-01