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

27 april 2026 uppdaterad av: Hu Zhicheng, First Affiliated Hospital, Sun Yat-Sen University

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.

Studieöversikt

Status

Rekrytering

Betingelser

Sår och skador / dödlighet

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

1000

Fas

Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Hu Zhicheng
Telefonnummer: 87755766-8265
E-post: huzhch5@mail.sysu.edu.cn

Studieorter

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina
    - Rekrytering
    - The First Affiliated Hospital of Sun Yat-sen University
    - Kontakt:
      
      The First Affiliated Hospital of Sun Yat-sen University
      
      Telefonnummer: 87755766-8265
      
      E-post: huzhch5@mail.sysu.edu.cn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Tilldelning: Icke-randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Ingen (Open Label)

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm	Intervention / Behandling
Experimentell: Rapid Tissue-Engineered Skin Group Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）	Procedur: 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.
Aktiv komparator: Traditional Composite Skin Graft Group	Procedur: 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.

Deltagargrupp / Arm

Intervention / Behandling

Experimentell: Rapid Tissue-Engineered Skin Group

Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）

Procedur: 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.

Aktiv komparator: Traditional Composite Skin Graft Group

Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Complete Wound Healing Rate Tidsram: At 4 weeks post-surgery	The percentage of participants achieving complete wound epithelialization （defined as 100% re-epithelialization without drainage or dressing requirements）	At 4 weeks post-surgery

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

31 december 2029

Avslutad studie (Beräknad)

1 december 2030

Studieregistreringsdatum

Först inskickad

14 april 2026

Först inskickad som uppfyllde QC-kriterierna

27 april 2026

Första postat (Faktisk)

1 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Sår och skador

Andra studie-ID-nummer

2026P-ZD025

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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