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

Italy, Netherlands, Switzerland, United Kingdom (ICTRP)

ICTRP Trial ID
NCT03229564 (ICTRP)

Official title (approved by ethics committee)
A Phase IIb, 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 partial deep dermal and full-thickness burns in children in comparison to autologous split-thickness skin grafts (STSG) With a sub-study at the sites a) Santobono Napoli (Italy), and b) Ospedale dei Bambini Vittore Buzzi Milano (Italy) SUBSTUDY TO PROTOCOL TBRU-dS-BC-PIIb-Study Title: An open-label, prospective, non-randomised, noncontrolled study to evaluate the survival of the paediatric patients with deep partial and full-thickness burns in a life threatening situation reated with EHSGKF, and to evaluate the safety and efficacy of EHSG-KF (BASEC)

Academic title
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) (ICTRP)

Public title
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children (ICTRP)

Disease under investigation
Burns (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: <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

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

- Patients with a known history of malignancy

- 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 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 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 (ICTRP)

not available

Primary and secondary end points
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface (ICTRP)

Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection;Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection;Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R);Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of general scar quality using POSAS assessment tool (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 Schiestl, Prof.;Clemens Schiestl, Prof., clemens.schiestl@kispi.uzh.ch, +41 44 266 73 93, University Children's Hospital, Zurich, (ICTRP)

Secondary trial IDs
TBRU-dS-BC-PIIb (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03229564 (ICTRP)