An interventional study of Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC) in Skin Wound Healing After Cesarean Section and Cesarean Section Scar Healing, sponsored by Asfendiyarov Kazakh National Medical University. Recruiting at 1 site in Kazakhstan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Asfendiyarov Kazakh National Medical University · Not applicable, Interventional, and Treatment
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:
611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 512 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Asfendiyarov Kazakh National Medical University is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Application of the bioengineered tissue construct (amniotic membrane and calcium alginate) on the postoperative skin incision after cesarean section.
Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
Routine postoperative wound care after cesarean section without tissue-engineered construct application.
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.
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.
Time frame: Preoperative baseline, Day 3, Day 28
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.
Time frame: Day 5-7, Day 28
Ultrasound-assessed scar thickness and echogenicity
Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging.
Time frame: 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).
Time frame: Week 12
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2025; primary completion for Dec 2026, 13 months later.
Of 173 non-industry interventional studies with no phase under Cicatrix, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 13 months is below that.
Counting every sponsor, half of 206 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
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Asfendiyarov Kazakh National Medical University