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Trial record 1 of 3 for:    EHSG-KF
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Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

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ClinicalTrials.gov Identifier: NCT03229564
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : February 8, 2023
Sponsor:
Collaborators:
Wyss Zurich
Julius Clinical
Sintesi Research Srl
University Hospital, Zürich
University of Zurich
Information provided by (Responsible Party):
CUTISS AG

Study Description
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Brief Summary:
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.

Condition or disease Intervention/treatment Phase
Burns Biological: EHSG-KF Biological: STSG Phase 2 Phase 3

Detailed Description:
This multicentre phase IIb clinical trial will target patients from 1-17 years 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
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Arm Intervention/treatment
Experimental: EHSG-KF and STSG Transplantation
Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area
 Biological: EHSG-KF
Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
Other Name: denovoSkin

Biological: STSG
Transplantation of autologous split-thickness skin graft to the control area
Other Name: Split-thickness skin graft


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface [ Time Frame: 4 weeks post grafting ]
    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 :
  1. Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection [ Time Frame: 4-11 days post grafting and 21 +/-2 days post grafting ]
    Evaluation of clinical signs of infection at experimental area and control area

  2. Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection [ Time Frame: 4-11 days post grafting and 21 +/-2 days post grafting ]
    Evaluation of microbiologic signs of infection at experimental area and control area

  3. Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R) [ Time Frame: 1 year +/-30 days post grafting ]
    Assessment of elasticity of experimental area and control area using Cutometer(R)

  4. 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 [ Time Frame: 1 year +/-30 days post grafting ]
    Assessment of general scar quality of experimental area and control area using POSAS assessment tool


Eligibility Criteria
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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Patients with a known history of malignancy
  • 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 or parents/legal guardian expected not to comply with the study protocol (including patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
  • Pregnant or breast feeding females
  • Suspicion of child abuse
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229564


Contacts
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Contact: Clemens Schiestl, Prof. +41 44 266 73 93 clemens.schiestl@kispi.uzh.ch

Locations
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Italy
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono Recruiting
Napoli, Italy
Contact: Marcello Zamparelli, Dr.         
Principal Investigator: Marcello Zamparelli, Dr.         
U.O.C. Grandi Ustionati Azienda Ospedale Università Padova Recruiting
Padova, Italy
Contact: Bruno Azzena, Prof.         
Principal Investigator: Bruno Azzena, Prof.         
Città della Salute Not yet recruiting
Torino, Italy, 10126
Contact: Maurizio Stella, Dott.    +39 11 693 34 25      
Principal Investigator: Maurizio Stella, Dott.         
U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona Not yet recruiting
Verona, Italy
Contact: Jasminka Minic, Dr.         
Principal Investigator: Jasminka Minic         
Netherlands
Rode Kruis Ziekenhuis Recruiting
Beverwijk, Netherlands, 1940
Contact: Esther Middelkoop, Prof.    +31 251 265 555      
Principal Investigator: Esther Middelkoop, Prof.         
Switzerland
University Children's Hospital Zurich Recruiting
Zurich, Switzerland, 8032
Contact: Sophie Böttcher, PD Dr. med.    +41 44 266 73 93      
Principal Investigator: Sophie Böttcher, PD Dr. med.         
Sponsors and Collaborators
CUTISS AG
Wyss Zurich
Julius Clinical
Sintesi Research Srl
University Hospital, Zürich
University of Zurich
Investigators
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Study Chair: Clemens Schiestl, Prof. University Children's Hospital, Zurich
More Information
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Responsible Party: CUTISS AG
ClinicalTrials.gov Identifier: NCT03229564    
Other Study ID Numbers: TBRU-dS-BC-PIIb
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CUTISS AG:
Burns
Scar
Skin
Wound healing
 Tissue Engineering
Dermis
Epidermis
Thermal Injuries
Additional relevant MeSH terms:
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Burns
Wounds and Injuries