NCT07241013

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Nov 2025Dec 2027

Study Start

First participant enrolled

November 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Skin Wound Healing After Cesarean SectionCesarean Section Scar Healing

Keywords

skin wound healingCesarean sectionpostoperative scaramniotic membranetissue-engineered constructepithelialization

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • POSAS clinical scar assessment (Observer and Patient Scale)

    Day 5-7, Day 28

  • Ultrasound-assessed scar thickness and echogenicity

    Day 3, Day 28

  • Cosmetic and photographic scar assessment

    Week 12

Study Arms (2)

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.

Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)

Standard Postoperative Care

NO INTERVENTION

Routine postoperative wound care after cesarean section without tissue-engineered construct application.

Interventions

Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)DEVICE

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.

Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as female and have a biological sex of female are eligible to participate in this study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 years and older.
  • Planned elective cesarean section for medical indications (breech presentation, multiple pregnancy, large fetus, uterine scar, etc.).
  • Absence of severe obstetric complications (e.g., preeclampsia, hemorrhage, placental abruption).
  • No decompensated chronic diseases or acute infections.
  • Signed written informed consent.

You may not qualify if:

  • Acute infectious, autoimmune, or oncological diseases.
  • Severe pregnancy complications (preeclampsia, eclampsia, decompensated gestational diabetes).
  • Emergency cesarean section.
  • Severe postpartum complications: massive bleeding (\>1000 mL), infection, abscess, severe anemia, allergic reactions to dressing materials.
  • Withdrawal of consent or inability to continue participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Perinatology and Pediatric Surgery (ЦПиДКХ)

Almaty, Kazakhstan

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
G.M.Issina, MD, PhD, Acting Professor of Obstetrics and Gynecology Department, KazNMU

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 21, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations

KA(1)