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

Asfendiyarov Kazakh National Medical University

Status: Enrolling

Conditions: Cesarean Section Scar Healing; Skin Wound Healing After Cesarean Section

Treatments: Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07241013

TEC-CS-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate)

Experimental group

Description:

Application of the bioengineered tissue construct (amniotic membrane and calcium alginate) on the postoperative skin incision after cesarean section.

Treatment:

Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)

Standard Postoperative Care

No Intervention group

Description:

Routine postoperative wound care after cesarean section without tissue-engineered construct application.