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Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

Primary Purpose

Burns

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

EHSG-KF

STSG

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Scar, Skin, Wound healing, Tissue Engineering, Dermis, Epidermis, Thermal Injuries

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: ≥12 years of age
Deep partial thickness and/or full thickness burns requiring surgical wound coverage
Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. >20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion.
Signed Informed consent

Exclusion Criteria:

Patients tested positive for HBV, HCV, syphilis or HIV
Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing)
Severe drug and alcohol abuse
Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN prior to the current hospital admission and / or at the Investigator's discretion
Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen
Previous enrolment of the patient into the current phase II study
Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study
Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
Pregnant or breast feeding females
Intention to become pregnant during the clinical course of the study (12 months)
Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands)
Enrolment of the Investigator, his/her family members, employees and other dependent persons

Sites / Locations

Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
Città della Salute
U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona
Rode Kruis Ziekenhuis
Maasstad Ziekenhuis
University Children's Hospital Zurich
University Hospital Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EHSG-KF and STSG Transplantation

Arm Description

Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area

Outcomes

Primary Outcome Measures

Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface

Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area

Secondary Outcome Measures

Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection

Evaluation of clinical signs of infection at experimental area and control area

Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection

Evaluation of microbiologic signs of infection at experimental area and control area

Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)

Assessment of elasticity of experimental area and control area using Cutometer(R)

Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of General scar quality using POSAS assessment tool

Assessment of general scar Quality of experimental area and control area using POSAS assessment tool

Full Information

NCT ID

NCT03227146

First Posted

July 7, 2017

Last Updated

February 7, 2023

Sponsor

CUTISS AG

Collaborators

Wyss Zurich, Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT03227146

Brief Title

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

Official Title

A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 25, 2017 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CUTISS AG

Collaborators

Wyss Zurich, Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.

Detailed Description

This multicentre phase IIb clinical trial will target adults and adolescents with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

Burns, Scar, Skin, Wound healing, Tissue Engineering, Dermis, Epidermis, Thermal Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EHSG-KF and STSG Transplantation

Arm Type

Experimental

Arm Description

Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area

Intervention Type

Biological

Intervention Name(s)

EHSG-KF

Other Intervention Name(s)

denovoSkin

Intervention Description

Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area

Intervention Type

Biological

Intervention Name(s)

STSG

Other Intervention Name(s)

Split-thickness skin graft

Intervention Description

Transplantation of autologous split-thickness skin graft to the control area

Primary Outcome Measure Information:

Title

Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface

Description

Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area

Time Frame

4 weeks post grafting

Secondary Outcome Measure Information:

Title

Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection

Description

Evaluation of clinical signs of infection at experimental area and control area

Time Frame

4-11 days post grafting and 21 +/-2 days post grafting

Title

Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection

Description

Evaluation of microbiologic signs of infection at experimental area and control area

Time Frame

4-11 days post grafting and 21 +/-2 days post grafting

Title

Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)

Description

Assessment of elasticity of experimental area and control area using Cutometer(R)

Time Frame

1 year +/-30 days post grafting

Title

Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of General scar quality using POSAS assessment tool

Description

Assessment of general scar Quality of experimental area and control area using POSAS assessment tool

Time Frame

1 year +/-30 days post grafting

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: ≥12 years of age Deep partial thickness and/or full thickness burns requiring surgical wound coverage Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients in The Netherlands) will remain open at 4 weeks post burn despite proceeding with treatment in accordance with the standard of care. >20% TBSA burns can be taken as guideline, but TBSA is not an inclusion criterion. Signed Informed consent Exclusion Criteria: Patients tested positive for HBV, HCV, syphilis or HIV Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind of congenital defect of metabolism including insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in the opinion of the Investigator, has the potential to significantly delay wound healing) Severe drug and alcohol abuse Pre-existing coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen <LLN prior to the current hospital admission and / or at the Investigator's discretion Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen Previous enrolment of the patient into the current phase II study Participation of the patient in another study with conflicting endpoints within 30 days preceding and during the present study Patients expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) Pregnant or breast feeding females Intention to become pregnant during the clinical course of the study (12 months) Wounds in the head and neck area as study target area (only applicable for study patients in The Netherlands) Enrolment of the Investigator, his/her family members, employees and other dependent persons

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clemens Schiestl, Prof.

Organizational Affiliation

University Children's Hospital, Zurich

Official's Role

Study Chair

Facility Information:

Facility Name

Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

City

Napoli

Country

Italy

Facility Name

Unità di Chirurgia Plastica e Ustioni Ospedale Santobono

City

Napoli

Country

Italy

Facility Name

U.O.C. Grandi Ustionati Azienda Ospedale Università Padova

City

Padova

Country

Italy

Facility Name

Città della Salute

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona

City

Verona

Country

Italy

Facility Name

Rode Kruis Ziekenhuis

City

Beverwijk

ZIP/Postal Code

1940

Country

Netherlands

Facility Name

Maasstad Ziekenhuis

City

Rotterdam

ZIP/Postal Code

3079

Country

Netherlands

Facility Name

University Children's Hospital Zurich

City

Zurich

ZIP/Postal Code

8032

Country

Switzerland

Facility Name

University Hospital Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

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