A study performed in more hospitals, to assess the safety and efficacy of a skin model that is engineered in the lab with cells of the patient (EHSG-KF) to use in treatment of full thickness burns in adults and children and compare this to the treatment with the own skin system called STSG.
- Conditions
- Adults and children with full thickness skin defectsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-002462-41-NL
- Lead Sponsor
- CUTISS AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
• Age: =1 year of age
• Large full-thickness defects that require coverage after excision
of:
o Scars
o Benign skin tumors (e.g. neurofibroma)
o Melanocytic nevus (e.g. giant nevus)
o Gender reassignment surgery
o Soft tissue defect after trauma
o Soft tissue defect after infection and debridement (e.g.
necrotizing fascitis, hidradentitis suppurativa, purpura
fulminans)
o Flap donor site (e.g. radial forearm flap)
• Minimal areas requiring coverage (not counting the head and neck
area for study patients in The Netherlands):
o Minimum: 1-5 years: 9 cm2
o Minimum: 6-16 years: 25 cm2
o Minimum: > 16 years: 45 cm2
• Signed informed consent from the patient or the
parents/legally authorized representative.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 4
• 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 • 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 or or parents/legally authorized representative 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method