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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Chirurgia Plastica e Centro 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
Padua, Italy
Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center
Amsterdam, Netherlands
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
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).
Time frame: 3 months post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using Cutometer for elasticity measurement
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Observer Total Score
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using POSAS ("Patient and Observer Scar Assessment Scale") Patient Items and Total Score
Time frame: 3 months and 1 year +/- 30 days post grafting
A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Evaluation of scar quality at experimental area and control area, using Colormeter for skin colour measurement,.
Time frame: 3 months and 1 year +/- 30 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation
Evaluation of efficacy at experimental area and control area, calculating the epithelialized area as percentage of the total grafted area.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
University Children's Hospital Zurich
Zurich, Switzerland
University Hospital Zurich
Zurich, Switzerland
Time frame: 28 +/- 3 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.
Evaluation of efficacy at experimental area and control area, assessed by the analysis of the graft take
Time frame: 4-11 days post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Pediatric quality of life inventory")
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Patient Observer Scar Assessment Scale")
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("EuroQuol 5 dimensions questionnaire")
Time frame: 1 +/- 30 days year post grafting
Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
Evaluation of efficacy of experimental and control treatment, assessed by quality of life questionnaires ("Burn Specific Health Scale Brief")
Time frame: 1 +/- 30 days year post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.
Evaluation of safety at experimental area and control area based on the infection rate, assessed by using wound swabs and clinical evaluation.
Time frame: 4-11 days and 19-23 days post grafting
Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.
Evaluation of safety at experimental area and control area, assessed by the type and number of adverse events.
Time frame: through study completion, an average of 3 years