A Phase IIb, 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 partial deep dermal and full thickness burns in children in comparison to autologous split-thickness skin grafts (STSG)

Phase 2

Conditions: ernstige brandwonden
dermal burns
skin damage due to heat

Registration Number: NL-OMON55737

Lead Sponsor: CUTISS AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 4

Inclusion Criteria

• Age: <12 years of age
• Deep partial thickness and/or full-thickness burns requiring surgical
wound coverage
• Expected that >=90 cm2 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. >20% TBSA burns can be taken as guideline, but TBSA is not an
inclusion criterion.
• Signed informed consent from the patient or the parents/legally authorized
representative.

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 / or at the Investigator*s discretion
• Patients with known allergies to amphotericin B, gentamicin, penicillin or
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 parents/legal guardian 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 non-accidental injury
•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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br>Efficacy evaluation, as a comparison between the EHSG-KF and control sites,<br /><br>based on:<br /><br>• Ratio of covered surface area to biopsy site/donor site surface area at visit<br /><br>6(28 +/-3 days post grafting)</p><br>

Secondary Outcome Measures