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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03227146
Other study ID # TBRU-dS-BA-PIIb
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 25, 2017
Est. completion date August 31, 2025

Study information

Verified date February 2024
Source CUTISS AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 14
Est. completion date August 31, 2025
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
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 U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona Verona
Netherlands Rode Kruis Ziekenhuis Beverwijk
Netherlands Maasstad Ziekenhuis Rotterdam
Switzerland University Children's Hospital Zurich Zurich
Switzerland University Hospital Zurich Zurich

Sponsors (6)

Lead Sponsor Collaborator
CUTISS AG Julius Clinical, Sintesi Research Srl, University Hospital, Zürich, University of Zurich, Wyss Zurich

Countries where clinical trial is conducted

Italy,  Netherlands,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 weeks post grafting
Secondary 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 4-11 days post grafting and 21 +/-2 days post grafting
Secondary 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 4-11 days post grafting and 21 +/-2 days post grafting
Secondary 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) 1 year +/-30 days post grafting
Secondary 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 1 year +/-30 days post grafting
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