Randomized, controlled, multinational, multicenter Phase II study to evaluate the efficacy and safety of a skin substitute product (EHSG-KF) for the treatment of deep skin defects in adults and children compared to autologous split-thickness skin grafts (STSG).

Italy, Netherlands, Switzerland, United Kingdom (ICTRP)

ICTRP Trial ID
NCT03394612 (ICTRP)

Official title (approved by ethics committee)
A Phase II, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermoepidermal skin substitute (EHSG-KF) for the treatment of full-thickness skin defects in adults and children in comparison to autologous split-thickness skin grafts (STSG) (BASEC)

Academic 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) (ICTRP)

Public title
Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children (ICTRP)

Disease under investigation
Skin Wound (ICTRP)

Intervention under investigation
Biological: EHSG-KFBiological: STSG (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion 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 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 (ICTRP)

not available

Primary and secondary end points
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality (ICTRP)

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;Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality;A 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 epithelialisation;Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.;Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.;Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.;Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.;Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.;Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.;Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events. (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
Wyss Zurich;Julius Clinical;Sintesi Research Srl;University Hospital, Z�rich;University of Zurich (ICTRP)

Additional contacts
Clemens Sc, Prof., University Children's Hospital, Zurich (ICTRP)

Secondary trial IDs
TBRU-dS-RAC-PII (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03394612 (ICTRP)