Amniotic membrane and calcium alginate dressing to help cesarean wounds heal
Official title: Development of an Innovative Method for Producing a Biodegradable Tissue-Engineered Construct From Amniotic Membrane for the Epithelialization of Postoperative Wounds
Run by Asfendiyarov Kazakh National Medical University · NCT07241013 · Data updated 2026-11-12
This trial will test whether a biodegradable dressing made from amniotic membrane and calcium alginate helps women having elective cesarean sections heal their surgical wound faster and form a better scar.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Asfendiyarov Kazakh National Medical University Academic / other |
| Locations | 1 site (Almaty) |
| Status | Recruiting |
| Started | November 2025 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07241013 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult women (18+) scheduled for an elective cesarean section without severe obstetric complications and able to provide informed consent are the intended participants.
✕Probably not a fit
Women having emergency cesarean sections, those with acute infections, severe pregnancy or postpartum complications, or certain autoimmune/oncologic conditions are unlikely to be eligible or to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized study will enroll 100 women undergoing planned cesarean section and assign them to either a tissue‑engineered construct (TEC) applied to the postoperative wound or to standard wound care. The TEC is a biodegradable combination of amniotic membrane and calcium alginate intended to promote epithelialization and reduce inflammation. Researchers will measure biological markers (including IL‑6 and IL‑10), ultrasound features of the scar, clinician‑rated POSAS scores, and patient‑reported cosmetic outcomes at up to 12 weeks. Safety and wound healing clinical endpoints will be compared between groups to determine whether the TEC improves scar quality and recovery.
Why it matters
Potential benefit: If successful, the dressing could speed wound closure, reduce inflammation, and improve the cosmetic appearance of cesarean scars.
How similar studies have gone: Previous small studies and case series using amniotic membrane or alginate‑based dressings have shown promising wound‑healing and anti‑inflammatory effects, but large randomized trials for cesarean scar improvement are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Center for Perinatology and Pediatric Surgery (ЦПиДКХ)
Almaty, Kazakhstan Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.