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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
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
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
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
Time frame: 4 weeks post grafting
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
Time frame: 4-11 days post grafting and 21 +/-2 days post grafting
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
Time frame: 4-11 days post grafting and 21 +/-2 days post grafting
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)
Time frame: 1 year +/-30 days post grafting
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
Time frame: 1 year +/-30 days post grafting
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University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
University Hospital Zurich
Zurich, Switzerland