Skin Wound Healing After Cesarean SectionNCT07241013
Tissue-Engineered Construct Based on Amniotic Membrane and Calcium Alginate for Cesarean Section Wound Healing
A study testing Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC) in people with Skin Wound Healing After Cesarean Section and Cesarean Section Scar Healing, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Skin Wound Healing After Cesarean Section, Cesarean Section Scar Healing
- What is being tested?
- Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKazakhstan
- Study dates
- Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazakhstan1 site, 1 recruiting
- Recruiting
Center for Perinatology and Pediatric Surgery (ЦПиДКХ)
Almaty
Issenova S.Sh. Professor, Head of the Department of Obstetrics and Gynecology, +77051727500, isenova.s@kaznmu.kz
About this study
Official title: Development of an Innovative Method for Producing a Biodegradable Tissue-Engineered Construct From Amniotic Membrane for the Epithelialization of Postoperative Wounds
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.
Read the detailed description
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:
- Experimental group - TEC application to the postoperative wound.
- 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.
- Being tested
- Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)
- Keywords
- skin wound healing, Cesarean section, postoperative scar, amniotic membrane, tissue-engineered construct, epithelialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative baseline, Day 3, Day 28
Secondary outcomes (3)
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.
Measured: Day 5-7, Day 28
Ultrasound-assessed scar thickness and echogenicity
Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging.
Measured: 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).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Wound Healing After Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asfendiyarov Kazakh National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan, Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan
- Responsible party
- Principal investigator, Gulzhan Muratovna Issina, Asfendiyarov Kazakh National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241013
- Sponsor's protocol ID
- TEC-CS-2025-01
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Innovative Method for Producing a Biodegradable Tissue-Engineered Construct From Amniotic Membrane for the Epithelialization of Postoperative Wounds
- ClinicalTrials.gov ID
- NCT07241013
- Acronym / sponsor ID
- TEC-CS-2025-01
- Keywords
- skin wound healing, Cesarean section, postoperative scar, amniotic membrane, tissue-engineered construct, epithelialization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asfendiyarov Kazakh National Medical UniversityUniversity, hospital or other
- Collaborators
- Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan, Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Experimental group - TEC application to the postoperative wound.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate) | Experimental | Device: Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC)Application of the bioengineered tissue construct (amniotic membrane and calcium alginate) on the postoperative skin incision after cesarean section. |
| Standard Postoperative Care | No intervention | –Routine postoperative wound care after cesarean section without tissue-engineered construct application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Tissue-Engineered Construct (Amniotic Membrane + Calcium Alginate) |
Primary outcome
Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration
Time frame: Preoperative baseline, Day 3, Day 28
Dynamic evaluation of systemic inflammatory response; IL-6, 10 levels measured by ELISA in peripheral blood.
3 secondary outcomes
POSAS clinical scar assessment (Observer and Patient Scale)
Time frame: Day 5-7, Day 28
Ultrasound-assessed scar thickness and echogenicity
Time frame: Day 3, Day 28
Cosmetic and photographic scar assessment
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Center for Perinatology and Pediatric Surgery (ЦПиДКХ)
Almaty, Kazakhstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue-engineered construct based on amniotic membrane and calcium alginate (TEC) in people with Skin Wound Healing After Cesarean Section and Cesarean Section Scar Healing, run by Asfendiyarov Kazakh National Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration (time frame: Preoperative baseline, Day 3, Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.