Clinical trial NCT03394612: Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
Official title: A Phase II, 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 Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Skin Wound
Keywords: Scar
Skin
Wound Healing
Tissue Engineering
Dermis
Epidermis
Lead sponsor: CUTISS AG
Sponsor class: INDUSTRY
Collaborators: name: Wyss Zurich
name: Julius Clinical
name: Sintesi Research Srl
name: University Hospital, Zürich
name: University of Zurich
First posted: 2018-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age: ≥1 years of age
* Large full-thickness defects that require coverage after excision of: Scars, Benign skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa, purpura fulminans), Flap donorsite (e.g. radial forearm flap)
* Minimal areas requiring coverage (not counting the head and neck area for study patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, \>16 years: minimum 45cm2
* 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)
* Enrolment of the Investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
timeFrame: 3 months post grafting
Secondary outcomes:
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
timeFrame: 3 months and 1 year +/- 30 days post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
timeFrame: 3 months and 1 year +/- 30 days post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
timeFrame: 3 months and 1 year +/- 30 days post grafting
measure: A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
timeFrame: 3 months and 1 year +/- 30 days post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation
timeFrame: 28 +/- 3 days post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.
timeFrame: 4-11 days post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
timeFrame: 1 +/- 30 days year post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
timeFrame: 1 +/- 30 days year post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
timeFrame: 1 +/- 30 days year post grafting
measure: Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.
timeFrame: 1 +/- 30 days year post grafting
measure: Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.
timeFrame: 4-11 days and 19-23 days post grafting
measure: Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
city: Napoli
country: Italy
facility: Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
city: Padova
country: Italy
facility: U.O.C. Grandi Ustionati Azienda Ospedale Università Padova
city: Amsterdam
country: Netherlands
facility: Dept. of Plastic, Reconstructive and Hand Surgery, VU University Medical Center
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Clemens Sc, Prof.
role: STUDY_CHAIR
References: