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

Rapid Construction of Tissue-engineered Skin for Repairing Difficult-to-heal Wounds: A Multicenter Real-world Study

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 Overview

• Status: Recruiting
• Conditions: Wounds and Injuries / Mortality
• Intervention / Treatment: Procedure: Rapid Tissue-Engineered Skin; Procedure: Traditional Composite Skin Graft

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hu Zhicheng; Phone Number: 87755766-8265; Email: huzhch5@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: The First Affiliated Hospital of Sun Yat-sen University; Phone Number: 87755766-8265; Email: huzhch5@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid Tissue-Engineered Skin Group; Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）	Procedure: Rapid 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.
Active Comparator: Traditional Composite Skin Graft Group	Procedure: Traditional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Wound Healing Rate	The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）	At 4 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Recurrence Rate	Incidence of wound recurrence at the healed site	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.	4 weeks, 3, 6, 12 months post-surgery
Functional Recovery	Sweat test for assessment of sweat gland regeneration	6, 12 months post-surgery
Mortality Rate	All-cause mortality	3, 6, 12 months post-surgery
Amputation Rate	Incidence of amputation （for chronic wound patients）	3, 6, 12 months post-surgery
Healing Trajectory	Wound healing rate at week 1, 2, 3; and time to complete healing	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.	From day of surgery through 12 months post-surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2026P-ZD025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No