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Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children

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ClinicalTrials.gov Identifier: NCT03394612
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
ETH Zurich (Switzerland)
Julius Clinical, The Netherlands
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.

Condition or disease Intervention/treatment Phase
Skin Wound Biological: EHSG-KF Biological: STSG Phase 2

Detailed Description:
This multicentre phase II clinical trial will target adults and children with fullt-thickness skin defects to elucidate the benefit of a tissue-engineered autologous skin substitute. Particular emphasis, apart from safety, will be placed on efficacy, e.g. scar quality, in comparison to meshed STSG.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, 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 Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2023

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




Primary Outcome Measures :
  1. Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality [ Time Frame: 3 months post grafting ]
    Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality, using the POSAS ("Patient and Observer Scar Assessment Scale"). The reported Observer Total Score can range from 1 (best) to 10 (worst).


Secondary Outcome Measures :
  1. Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality [ Time Frame: 3 months and 1 year +/- 30 days post grafting ]
    Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement

  2. Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality [ Time Frame: 3 months and 1 year +/- 30 days post grafting ]
    Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Observer Total Score

  3. Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality [ Time Frame: 3 months and 1 year +/- 30 days post grafting ]
    Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score

  4. A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality [ Time Frame: 3 months and 1 year +/- 30 days post grafting ]
    Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,.

  5. Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation [ Time Frame: 28 +/- 3 days post grafting ]
    Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area.

  6. Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take. [ Time Frame: 4-11 days post grafting ]
    Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take

  7. Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. [ Time Frame: 1 +/- 30 days year post grafting ]
    Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory")

  8. Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. [ Time Frame: 1 +/- 30 days year post grafting ]
    Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Patient Observer Scar Assessment Scale")

  9. Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. [ Time Frame: 1 +/- 30 days year post grafting ]
    Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("EuroQuol 5 dimensions questionnaire")

  10. Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life. [ Time Frame: 1 +/- 30 days year post grafting ]
    Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief")

  11. Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate. [ Time Frame: 4-11 days and 19-23 days post grafting ]
    Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation.

  12. Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events. [ Time Frame: through study completion, an average of 3 years ]
    Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥18 years of age
  • Large full-thickness defects that require coverage after reconstructive and elective procedures
  • 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 allergic to amphotericin B and gentamicin
  • 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)
  • Enrolment of the Investigator, his/her family members, employees and other dependent persons

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): NCT03394612


Contacts
Contact: Clemens Schiestl, PD Dr. +41 44 266 74 13 clemens.schiestl@kispi.uzh.ch

Locations
Netherlands
Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center Not yet recruiting
Amsterdam, Netherlands, 1081
Contact: Esther Middelkoop, Prof.         
Rode Kruis Ziekenhuis Not yet recruiting
Beverwijk, Netherlands, 1940
Contact: Esther Middelkoop, Prof.    +31 251 26 52 83    emiddelkoop@rkz.nl   
Principal Investigator: Esther Middelkoop, Prof.         
Switzerland
University Children's Hospital Zurich Recruiting
Zurich, Switzerland, 8032
Contact: Meuli Martin, Prof.    +41 44 266 74 02    martin.meuli@kispi.uzh.ch   
Principal Investigator: Martin Meuli, Prof.         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Jan Plock, Prof.    +41 44 255 27 38    jan.plock@usz.ch   
Principal Investigator: Jan Plock, Prof.         
United Kingdom
University Hospitals Birmingham Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Naiem Moiemen, Prof.    +31 30 656 9941    naiem.moiemen@uhb.nhs.uk   
Principal Investigator: Naiem Moiemen, Prof.         
University Hospitals Birmingham Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Yvonne Wilson    +44 121 371 48 71    yvonne.wilson@uhb.nhs.uk   
Principal Investigator: Yvonne Wilson, Prof.         
Sponsors and Collaborators
University of Zurich
ETH Zurich (Switzerland)
Julius Clinical, The Netherlands
Investigators
Study Director: Ernst Reichmann, Prof. University of Zurich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03394612     History of Changes
Other Study ID Numbers: TBRU-dS-RAC-PII
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
Scar
Skin
Wound Healing
Tissue Engineering
Dermis
Epidermis