Wounds and Injuries / Mortality
Conditions
Brief summary
This multicenter real-world study evaluates the efficacy and safety of a novel technique for rapid intraoperative construction of tissue-engineered skin using autologous epidermal stem cells （EpiSCs） for repairing difficult-to-heal wounds. Eligible patients are randomized to receive either: （1） the experimental intervention （rapidly constructed EpiSCs-loaded scaffold combined with split-thickness skin graft via one-step or two-step procedure）， or （2） control intervention （acellular scaffold combined with split-thickness skin graft）. The primary outcome is the complete wound healing rate at 4 weeks post-surgery. Secondary outcomes include wound recurrence, scar quality （VSS/POSAS）， functional recovery （sweat test）， mortality, amputation rate, and safety profile.
Interventions
PROCEDURERapid Tissue-Engineered Skin
Autologous split-thickness skin (0.15-0.2 mm) is harvested from the donor site at a donor-to-wound area ratio of 1:20-30. The harvested skin is processed using a specialized cell sorter to isolate autologous epidermal stem cells (EpiSCs) with \>93% viability within 30 minutes. The cell suspension is adjusted to a concentration of ≥1×10⁶ cells/mL and loaded onto a tissue-engineered scaffold via spraying or immersion (3-5 minutes). The cell-seeded scaffold is then applied to the wound bed. Depending on wound condition: (1) One-step procedure: scaffold and a split-thickness skin graft (0.15-0.2 mm) are applied simultaneously; (2) Two-step procedure: scaffold is implanted first, followed by split-thickness skin graft at 14±3 days post-primary surgery. Negative pressure wound therapy (-100 to -125 mmHg) is applied as needed.
PROCEDURETraditional Composite Skin Graft
The same tissue-engineered scaffold (without cell loading) is used. Autologous split-thickness skin graft (0.15-0.2 mm thickness) is harvested. The acellular scaffold is applied to the debrided wound bed followed by coverage with the split-thickness skin graft. The surgical procedure, postoperative wound care, negative pressure wound therapy (-100 to -125 mmHg when indicated), and follow-up protocol are identical to those in the experimental arm. This comparator represents the current standard of care for composite skin grafting in the participating centers.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All-age population Wounds requiring surgical repair （single area 10-100 cm²）： acute wounds （burns, traumatic defects, post-scar resection） OR chronic wounds （diabetic foot ulcers, pressure injuries, vascular ulcers） Completed wound bed preparation （no necrotic tissue, infection controlled） Signed informed consent and agreement to use tissue-engineered materials and long-term follow-up
Exclusion criteria
* History of allergy to allogeneic/xenogeneic tissue-engineered scaffolds or collagen materials Severe immunosuppression （HIV/AIDS, long-term immunosuppressant use） Malignant tumors, uncontrolled systemic infection （CRP \> 50 mg/L）， or organ failure （Child-Pugh Class C） Mental illness preventing compliance with treatment or follow-up Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing Rate | At 4 weeks post-surgery | The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Recurrence Rate | 3, 6, 12 months post-surgery | Incidence of wound recurrence at the healed site |
| Scar Quality Assessment | 4 weeks, 3, 6, 12 months post-surgery | Scar quality is assessed using the Vancouver Scar Scale (VSS) and the Patient and Observer Scar Assessment Scale (POSAS) at 4 weeks, 3, 6, and 12 months post-surgery. The VSS total score ranges from 0 to 13, with higher scores indicating worse scar outcome (assessing vascularity, pigmentation, pliability, and height). The POSAS includes two separate subscales: the Observer Scale (6 items, each scored 1 to 10, total range 6-60) and the Patient Scale (6 items, each scored 1 to 10, total range 6-60). For both POSAS subscales, higher scores represent worse scar outcome. |
| Functional Recovery | 6, 12 months post-surgery | Sweat test for assessment of sweat gland regeneration |
| Mortality Rate | 3, 6, 12 months post-surgery | All-cause mortality |
| Amputation Rate | 3, 6, 12 months post-surgery | Incidence of amputation （for chronic wound patients） |
| Healing Trajectory | 1, 2, 3 weeks post-surgery | Wound healing rate at week 1, 2, 3; and time to complete healing |
| Safety Outcome | From day of surgery through 12 months post-surgery | Safety outcome is the incidence of postoperative complications (including infection, hematoma, and graft failure), adverse events, and serious adverse events, assessed from the day of surgery through study completion, an average of 12 months. |
Countries
China
Contacts
CONTACTHu Zhicheng
Outcome results
None listed