Wound
Conditions
Keywords
wound, tissue-engineered skin
Brief summary
This randomized controlled trial evaluated a single-stage treatment for full-thickness skin defects using an autologous epidermal stem cell (EpiSC)-enriched cell suspension prepared during surgery. Participants received either standard treatment with an acellular dermal matrix and a split-thickness skin graft, or the same treatment with the addition of the EpiSC-enriched cell suspension. The study was designed to determine whether adding the cell suspension could improve wound healing and scar quality while maintaining treatment safety. Wound healing, wound recurrence, scar quality, and adverse events were assessed during follow-up.
Detailed description
Full-thickness skin defects caused by burns, ulcers, scars, trauma, or other conditions can result in functional impairment, visible scarring, and substantial reconstructive challenges. Conventional split-thickness skin grafting is widely used for wound closure, but graft contraction, delayed vascularization, donor-site morbidity, and suboptimal scar quality may limit clinical outcomes. Tissue-engineered skin combines a supporting matrix with viable cells to more closely reproduce the structure and function of native skin. Epidermal stem cells (EpiSCs) are of particular interest because of their potential roles in epithelial regeneration, angiogenesis, immune modulation, and extracellular matrix remodeling. However, conventional cell-based approaches may require prolonged in vitro culture and specialized facilities, limiting their routine clinical use. In this study, the investigators used a standardized intraoperative cell isolation system to prepare an autologous EpiSC-enriched basal cell suspension from residual fragments of split-thickness skin graft obtained from the participant during surgery. The cell suspension was prepared and applied immediately without prolonged in vitro expansion. In the standard-treatment group, the prepared wound bed was covered with an acellular dermal matrix followed by a split-thickness skin graft. In the cell-therapy group, the EpiSC-enriched suspension was first applied to the wound bed, followed by placement of the acellular dermal matrix. A second application of the cell suspension was then made to the surface of the matrix before the split-thickness skin graft was placed. Postoperative wound care was performed using the same general protocol in both groups. The study was designed to evaluate whether adding an intraoperatively prepared autologous EpiSC-enriched cell suspension to conventional composite grafting could improve the quality of full-thickness wound repair.
Interventions
PROCEDUREEpiSC-Enhanced Composite Grafting
Participants received acellular dermal matrix (ADM) and split-thickness skin grafting (STSG) combined with an intraoperatively prepared autologous epidermal stem cell (EpiSC)-enriched basal cell suspension. The cell suspension was first applied to the wound bed, followed by placement of the ADM. A second application of the cell suspension was made to the ADM surface, and the STSG was then overlaid.
PROCEDUREStandard Composite Grafting
Participants received standard composite grafting consisting of acellular dermal matrix (ADM) applied to the prepared wound bed and immediately covered with a split-thickness skin graft (STSG), without application of the EpiSC-enriched cell suspension.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients requiring skin grafting for full-thickness skin defects caused by burns, ulcers, scars, or other conditions. Wound area greater than 9 cm². Willing to participate in the clinical trial, provide written informed consent, and comply with follow-up requirements. For minors, consent was provided by a legal guardian. Mentally capable of understanding and following medical instructions.
Exclusion criteria
Known allergy to trypsin or collagen. Acute systemic infection, uncontrolled severe disease, or serious organ dysfunction. Planned pregnancy during the study period or within 6 months after skin grafting. Malignant tumors, autoimmune diseases, or use of high-dose glucocorticoids, defined as ≥40 mg prednisone per day or an equivalent dose for ≥2 weeks. Positive bacterial culture indicating wound infection. Limb vascular neuropathy. Expected inability to survive during the study period. Participation in another clinical study within the previous 12 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Quality Assessed by the Vancouver Scar Scale (VSS) | 6 months after treatment | Scar quality was assessed using the Vancouver Scar Scale (VSS), which evaluates four domains: pigmentation, vascularity, pliability, and height. Each domain was scored independently by two experienced blinded clinicians, and the average scores were used for analysis. The total VSS score ranges from 0 to 13, with lower scores indicating better scar quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing | postsurgery week 2 | Complete wound healing was defined as complete epithelialization of the target wound with no signs of infection or inflammation. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJiayuan Zhu, doctor
First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed