Tissue-Engineered Construct Based on Amniotic Membrane and Calcium Alginate for Cesarean Section Wound Healing
NCT ID: NCT07241013
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-30
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate)
Application of the bioengineered tissue construct (amniotic membrane and calcium alginate) on the postoperative skin incision after cesarean section.
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.
Standard Postoperative Care
Routine postoperative wound care after cesarean section without tissue-engineered construct application.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan
UNKNOWN
Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan
UNKNOWN
Asfendiyarov Kazakh National Medical University
OTHER
Responsible Party
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Gulzhan Muratovna Issina
G.M.Issina, MD, PhD, Acting Professor of Obstetrics and Gynecology Department, KazNMU
Locations
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Center for Perinatology and Pediatric Surgery (ЦПиДКХ)
Almaty, , Kazakhstan
Countries
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Facility Contacts
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Issenova S.Sh. Professor, Head of the Department of Obstetrics and Gynecology
Role: primary
Other Identifiers
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TEC-CS-2025-01
Identifier Type: -
Identifier Source: org_study_id
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