We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    EHSG-KF
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227146
Recruitment Status : Active, not recruiting
First Posted : July 24, 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 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 Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : November 30, 2022
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03227146


Locations
Layout table for location information
Italy
Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Napoli, Italy
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Napoli, Italy
U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
Padova, Italy
Città della Salute
Torino, Italy, 10126
U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands, 1940
Maasstad Ziekenhuis
Rotterdam, Netherlands, 3079
Switzerland
University Children's Hospital Zurich
Zurich, Switzerland, 8032
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
CUTISS AG
Wyss Zurich
Julius Clinical
Sintesi Research Srl
University Hospital, Zürich
University of Zurich
Investigators
Layout table for investigator information
Study Chair: Clemens Schiestl, Prof. University Children's Hospital, Zurich
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: CUTISS AG
ClinicalTrials.gov Identifier: NCT03227146    
Other Study ID Numbers: TBRU-dS-BA-PIIb
First Posted: July 24, 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

Layout table for additional information
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:
Layout table for MeSH terms
Burns
Wounds and Injuries