A study to check if the use of a skin model engeneered in the laboratory byusing your own skin cells (EHSG-KF), is safe and effective to treat partialdeep dermal and full thickness burns in children in comparison to thestandard treatment used in current medicine (STSG).
- Conditions
- Children with partial deep dermal and full thickness burns.Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2017-002461-21-IT
- Lead Sponsor
- niversity of Zurich, Tissue Biology Research Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 12
? Age: 1-17 years of age
? Deep partial thickness and/or full-thickness burns requiring
surgical wound coverage
? The following two criteria must be met:
o Expected that =90cm2 of wound (not counting the head
and neck area for study patients in The Netherlands) will
remain open at 4 weeks post burn despite proceeding with
treatment in accordance with the standard of care,
o >25% TBSA burn
? 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: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
? 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
? Patients with a known history of malignancy
? Pre-existing coagulation disorders as defined by INR outside its
normal value, PTT >ULN and fibrinogen hospital admission and / or at the Investigator’s discretion
? Patients allergic to amphotericin B and gentamicin
? 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 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
? Suspicion of child abuse
? 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