Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Diese Studie wird bei Personen ab 1 Jahr durchgeführt, die aufgrund eines Hautdefektes (z.B. wegen einer zurückliegenden Verbrennung, eines gutartigen Tumors oder eines Nävus) eine Hauttransplantation benötigen. Sie wird in verschiedenen Ländern und Spitälern (Zentren) durchgeführt: in Zürich, Schweiz, in Beverwijk, Niederlanden und in Turin, Italien.
Es werden zwei Hautflächen mit Hautdefekten ausgewählt und gemäss einer Zufallsverteilung wird eine Hautfläche mit EHSG-KF und die andere mit der Eigenhaut versorgt. Während der Visiten nach der Transplantation werden beide Verpflanzungen anhand ihrer Sicherheit und Wirksamkeit kontrolliert.
EHSG-KF ist bisher weder in der Schweiz noch in einem anderen Land zugelassen und wird mit der Verpflanzung dünner Eigenhaut (Standardverfahren) verglichen. EHSG-KF wurde bisher schon bei Menschen (kleine Anzahl von Patienten) und Tieren getestet. Wir möchten insgesamt 20 Patienten einschliessen, davon ungefähr 5 im Kinderspital Zürich und ungefähr 5 im Universitätsspital Zürich.
Diese Studie umfasst 12 Visiten während 3 Jahren: 2 vor der Verpflanzung, die
Verpflanzung, 7 Kontrollvisiten innerhalb des ersten Jahres, 2 Langzeitvisiten (einmal pro Jahr).
Malattie studiate(Fonte di dati: BASEC)
Hautdefekt
Health conditions
(Fonte di dati: WHO)
Skin Wound
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Transplantation von Hautersatzprodukt auf Hautdefekt
Interventions
(Fonte di dati: WHO)
Biological: EHSG-KF;Biological: STSG
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
- Alter: > 1 Jahr
- Tiefer Hautdefekt welcher eine chirurgische Behandlung benötigt
- Einverständnis des Patienten / der Eltern
Criteri di esclusione
(Fonte di dati: BASEC)
- Positives Hepatitis-B, Hepatitis-C, Syphilis oder HIV Test-Ergebnis
- Bekannte Grund- oder Begleiterkrankungen, die eine normale Wundheilung negativ beeinflussen können
- Bekannte Blutgerinnungsstörung
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 1 Year
Inclusion Criteria:
- Age: =1 years of age
- Large full-thickness defects that require coverage after excision of: Scars, Benign
skin tumors (e.g. neurofibroma), Melanocytic nevus (e.g. giant nevus), Gender
reassignment surgery, Soft tissue defect after trauma, Soft tissue defect after
infection and debridement (e.g necrotizingn fascitis, hidadentitis suppurativa,
purpura fulminans), Flap donorsite (e.g. radial forearm flap)
- Minimal areas requiring coverage (not counting the head and neck area for study
patients in The Netherlands): 1-5 years: minimum 9cm2, 6-16 years: minimum 25cm2, >16
years: minimum 45cm2
- 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)
- Enrolment of the Investigator, his/her family members, employees and other dependent
persons
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
A Phase II, 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 Full-Thickness Defects in Adults and Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 2
Punti finali primari
(Fonte di dati: WHO)
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality
Punti finali secondari
(Fonte di dati: WHO)
Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality;A Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality;Efficacy of EHSG-KF in comparison to STSG based on the assessment of epithelialisation;Efficacy of EHSG-KF in comparison to STSG based on the assessment of graft take.;Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.;Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.;Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Italy, Netherlands, Switzerland, United Kingdom
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Christin Roeskes
+41 44 266 33 79
studien.plastische@kispi.uzh.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Clemens Sc, Prof.
University Children's Hospital, Zurich
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Clemens Sc, Prof.
University Children's Hospital, Zurich
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
05.11.2018
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2017-02079
Secondary ID (Fonte di dati: WHO)
TBRU-dS-RAC-PII
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