Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds

First Affiliated Hospital, Sun Yat-Sen University1,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Wounds and Injuries / Mortality

Interventions

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.

Traditional Composite Skin GraftPROCEDURE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Complete Wound Healing Rate

The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）

Time frame: At 4 weeks post-surgery

Secondary Outcomes

Wound Recurrence Rate

Incidence of wound recurrence at the healed site

Time frame: 3, 6, 12 months post-surgery

Scar Quality Assessment

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.

Time frame: 4 weeks, 3, 6, 12 months post-surgery

Functional Recovery

Sweat test for assessment of sweat gland regeneration

Time frame: 6, 12 months post-surgery

Mortality Rate

All-cause mortality

Time frame: 3, 6, 12 months post-surgery

Amputation Rate

Incidence of amputation （for chronic wound patients）

Time frame: 3, 6, 12 months post-surgery

Healing Trajectory

Wound healing rate at week 1, 2, 3; and time to complete healing

Time frame: 1, 2, 3 weeks post-surgery

Safety Outcome

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.

Time frame: From day of surgery through 12 months post-surgery

Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts