Study on the efficacy and safety of an autologous (from the patient's skin cells) skin substitute product for the treatment of skin defects

Italy, Netherlands, Switzerland, United Kingdom (ICTRP)

ID di studio ICTRP
NCT03227146 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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 Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG) (BASEC)

Titolo accademico
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 Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG) (ICTRP)

Titolo pubblico
Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents (ICTRP)

Malattie studiate
Burns (ICTRP)

Intervento studiato
Biological: EHSG-KF;Biological: STSG (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: All
Maximum age: N/A
Minimum age: 12 Years
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

- 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)

- 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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Wyss Zurich;Julius Clinical;Sintesi Research Srl;University Hospital, Z?rich;University of Zurich (ICTRP)

Contatti aggiuntivi
Clemens Schiestl, Prof., University Children's Hospital, Zurich (ICTRP)

ID secondari
TBRU-dS-BA-PIIb (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03227146 (ICTRP)