[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611471":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":45,"overallOfficials":26,"centralContacts":26,"locations":51,"responsibleParty":70,"collaborators":74,"id":80,"slug":26,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":26,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Asfendiyarov Kazakh National Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"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",{"measure":19,"description":20,"timeFrame":21},"Ultrasound-assessed scar thickness and echogenicity","Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging.","Day 3, Day 28",{"measure":23,"description":24,"timeFrame":25},"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",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","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.\n\nA total of 100 participants will be randomized into two groups:\n\n1. Experimental group - TEC application to the postoperative wound.\n2. 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.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"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.",[40],"Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)",{"label":42,"type":43,"description":44,"interventionNames":26},"Standard Postoperative Care","NO_INTERVENTION","Routine postoperative wound care after cesarean section without tissue-engineered construct application.",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":26},"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.",[36],[52],{"facility":53,"status":54,"city":55,"state":26,"zip":26,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Center for Perinatology and Pediatric Surgery (ЦПиДКХ)","RECRUITING","Almaty","Kazakhstan","KZ",{"type":59,"coordinates":60},"Point",[61,62],76.9115,43.25249,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},"Issenova S.Sh. Professor, Head of the Department of Obstetrics and Gynecology","CONTACT","+77051727500","isenova.s@kaznmu.kz",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Gulzhan Muratovna Issina","G.M.Issina, MD, PhD, Acting Professor of Obstetrics and Gynecology Department, KazNMU",[75,78],{"name":76,"class":77},"Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan","UNKNOWN",{"name":79,"class":77},"Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan","100611471",false,"NCT07241013","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","Inclusion Criteria:\n\n1. Women aged 18 years and older.\n2. Planned elective cesarean section for medical indications (breech presentation, multiple pregnancy, large fetus, uterine scar, etc.).\n3. Absence of severe obstetric complications (e.g., preeclampsia, hemorrhage, placental abruption).\n4. No decompensated chronic diseases or acute infections.\n5. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Acute infectious, autoimmune, or oncological diseases.\n2. Severe pregnancy complications (preeclampsia, eclampsia, decompensated gestational diabetes).\n3. Emergency cesarean section.\n4. Severe postpartum complications: massive bleeding (\\>1000 mL), infection, abscess, severe anemia, allergic reactions to dressing materials.\n5. Withdrawal of consent or inability to continue participation.","FEMALE","18 Years",{"count":89,"type":90},100,"ESTIMATED","INTERVENTIONAL",[93],"NA","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.",[96,97],"Skin Wound Healing After Cesarean Section","Cesarean Section Scar Healing",[99,100,101,102,103,104],"skin wound healing","Cesarean section","postoperative scar","amniotic membrane","tissue-engineered construct","epithelialization","2025-11-16",{"date":107,"type":108},"2025-11-21","ACTUAL",{"date":110,"type":90},"2025-11",{"date":112,"type":90},"2027-12",{"name":5,"class":6},1]