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

Asfendiyarov Kazakh National Medical University100 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Skin Wound Healing After Cesarean Section Cesarean Section Scar Healing

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women aged 18 years and older. 2. Planned elective cesarean section for medical indications (breech presentation, multiple pregnancy, large fetus, uterine scar, etc.). 3. Absence of severe obstetric complications (e.g., preeclampsia, hemorrhage, placental abruption). 4. No decompensated chronic diseases or acute infections. 5. Signed written informed consent. Exclusion Criteria: 1. Acute infectious, autoimmune, or oncological diseases. 2. Severe pregnancy complications (preeclampsia, eclampsia, decompensated gestational diabetes). 3. Emergency cesarean section. 4. Severe postpartum complications: massive bleeding (\>1000 mL), infection, abscess, severe anemia, allergic reactions to dressing materials. 5. Withdrawal of consent or inability to continue participation.

Outcomes

Primary Outcomes

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.

Time frame: Preoperative baseline, Day 3, Day 28

Secondary Outcomes

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.

Time frame: Day 5-7, Day 28

Ultrasound-assessed scar thickness and echogenicity

Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging.

Time frame: Day 3, Day 28

Cosmetic and photographic scar assessment

Remote follow-up with voluntary photographic documentation and patient self-assessment of cosmetic outcomes (color, relief, discomfort, satisfaction).

Time frame: Week 12