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

27. april 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Sår og skader / dødelighet

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1000

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Ikke-randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Rapid Tissue-Engineered Skin Group Rapid intraoperative construction of autologous EpiSCs-loaded scaffold + split-thickness skin graft （one-step or two-step procedure）	Fremgangsmåte: 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	Fremgangsmåte: 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.

Deltakergruppe / Arm

Intervensjon / Behandling

Eksperimentell: Rapid Tissue-Engineered Skin Group

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

Fremgangsmåte: 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

Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Complete Wound Healing Rate Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Wound Recurrence Rate Tidsramme: 3, 6, 12 months post-surgery	Incidence of wound recurrence at the healed site	3, 6, 12 months post-surgery
Scar Quality Assessment Tidsramme: 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 Tidsramme: 6, 12 months post-surgery	Sweat test for assessment of sweat gland regeneration	6, 12 months post-surgery
Mortality Rate Tidsramme: 3, 6, 12 months post-surgery	All-cause mortality	3, 6, 12 months post-surgery
Amputation Rate Tidsramme: 3, 6, 12 months post-surgery	Incidence of amputation （for chronic wound patients）	3, 6, 12 months post-surgery
Healing Trajectory Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2026

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

14. april 2026

Først innsendt som oppfylte QC-kriteriene

27. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Sår og skader

Andre studie-ID-numre

2026P-ZD025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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