Cesarean Section Scar Healing, Skin Wound Healing After Cesarean Section
Conditions
Keywords
skin wound healing, Cesarean section, postoperative scar, amniotic membrane, tissue-engineered construct, epithelialization
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.
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: 1. Experimental group - TEC application to the postoperative wound. 2. 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.
Interventions
DEVICETissue-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.
Sponsors
Center for Perinatology and Pediatric Surgery, Almaty, Kazakhstan
Zhalyn Scientific and Technical Production Center, Almaty, Kazakhstan
Asfendiyarov Kazakh National Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum interleukin-6 (IL-6), interleukin-10 (IL-10) concentration | Preoperative baseline, Day 3, Day 28 | Dynamic evaluation of systemic inflammatory response; IL-6, 10 levels measured by ELISA in peripheral blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POSAS clinical scar assessment (Observer and Patient Scale) | Day 5-7, Day 28 | 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. |
| Ultrasound-assessed scar thickness and echogenicity | Day 3, Day 28 | Quantitative ultrasound assessment of postoperative scar (thickness, echogenicity, and vascularization) using Doppler imaging. |
| Cosmetic and photographic scar assessment | Week 12 | Remote follow-up with voluntary photographic documentation and patient self-assessment of cosmetic outcomes (color, relief, discomfort, satisfaction). |
Countries
Kazakhstan
Outcome results
None listed