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| Name | Class |
|---|---|
| Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan | UNKNOWN |
| Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate) | Experimental | Application of the bioengineered tissue construct (amniotic membrane and calcium alginate) on the postoperative skin incision after cesarean section. |
|
| Standard Postoperative Care | No Intervention | Routine postoperative wound care after cesarean section without tissue-engineered construct application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperative baseline, Day 3, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 5-7, Day 28 |
| Ultrasound-assessed scar thickness and echogenicity |
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Inclusion Criteria:
Exclusion Criteria:
Only individuals who self-identify as female and have a biological sex of female are eligible to participate in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Perinatology and Pediatric Surgery (ЦПиДКХ) | Recruiting | Almaty | Kazakhstan |
Individual participant data (IPD) will not be shared because the study involves a limited number of participants and includes sensitive personal and clinical data. Data will be used only within the study team for scientific analysis and publication in aggregated form.
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Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging. |
| 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). | Week 12 |