Trials / Recruiting
RecruitingNCT07241013
Tissue-Engineered Construct Based on Amniotic Membrane and Calcium Alginate for Cesarean Section Wound Healing
Development of an Innovative Method for Producing a Biodegradable Tissue-Engineered Construct From Amniotic Membrane for the Epithelialization of Postoperative Wounds
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Asfendiyarov Kazakh National Medical University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2025-11-21
- Last updated
- 2025-11-21
Locations
1 site across 1 country: Kazakhstan
Source: ClinicalTrials.gov record NCT07241013. Inclusion in this directory is not an endorsement.