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

27. april 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Sår og skader / dødelighed

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1000

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 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.
Aktiv komparator: 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.

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: 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.

Aktiv komparator: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

14. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Sår og skader

Andre undersøgelses-id-numre

2026P-ZD025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Kliniske forsøg med Rapid Tissue-Engineered Skin

Hadassah Medical Organization

Afsluttet

Biologisk lim til første grads perineale tårer

Grad 1 Perineal tårer

Israel

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