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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2022

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.

Interventions

  • Biological: EHSG-KF
    • Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
  • Biological: STSG
    • Transplantation of autologous split-thickness skin graft to the control area

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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)
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CUTISS AG
  • Collaborator
    • Wyss Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clemens Schiestl, Prof., Study Chair, University Children’s Hospital, Zurich

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