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SNCTP000003493 | NCT03394612 | BASEC2017-02079

Randomisierte, kontrollierte, multinationale, multizentrische Phase II Studie zur Überprüfung der Wirksamkeit und Sicherheit von einem Hautersatzprodukt (EHSG-KF) zur Behandlung von tiefen Hautdefekten bei Erwachsenen und Kindern im Vergleich zu autologen Spalthaut-Hauttransplantaten (STSG).

Data source: BASEC (Imported from 25.09.2020), WHO (Imported from 20.09.2020)
Changed: 01.09.2020
Disease category: Skin and Connective Tissues diseases (non cancer)

Brief description of trial (Data source: 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: Kinderspital Zürich, Schweiz; Universitätsspital Zürich, Schweiz; Rotes Kreuz Krankenhaus Beverwijk, Niederlanden.
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).

Health conditions investigated (Data source: BASEC)

Hautdefekt

Health conditions (Data source: WHO)

Skin Wound

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Transplantation von Hautersatzprodukt auf Hautdefekt

Interventions (Data source: WHO)

Biological: EHSG-KF;Biological: STSG

Criteria for participation in trial (Data source: BASEC)

- Alter: > 1 Jahr
- Tiefer Hautdefekt welcher eine chirurgische Behandlung benötigt
- Einverständnis des Patienten / der Eltern

Exclusion criteria (Data source: 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 (Data source: WHO)


Inclusion Criteria:

- Age: =18 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 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 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03394612

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03394612

Further information on trial

Date trial registered

07.12.2017

Incorporation of the first participant

14.02.2018

Recruitment status

Recruiting

Academic title (Data source: 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)

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Efficacy of EHSG-KF in comparison to STSG based on the assessment of scar quality

Secundary end point (Data source: WHO)

Safety of EHSG-KF in comparison to STSG based on the assessment of adverse events.;Safety of EHSG-KF in comparison to STSG based on the assessment of infection rate.;Efficacy of EHSG-KF in comparison to STSG based on the assessment of quality of life.;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 epithelialisation;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 scar quality

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Italy, Netherlands, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Jenny Bressan
+41 44 266 70 78
studien.plastische@kispi.uzh.ch

Contact for general information (Data source: WHO)

Ernst Reichmann, Prof.;Clemens Schiestl, Prof.
University of Zurich
+41 44 266 73 93
clemens.schiestl@kispi.uzh.ch

Contact for scientific information (Data source: WHO)

Ernst Reichmann, Prof.;Clemens Schiestl, Prof.
University of Zurich
+41 44 266 73 93
clemens.schiestl@kispi.uzh.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

University of Zurich

Additional sponsors (Data source: WHO)

Wyss Zurich;Julius Clinical, The Netherlands;Sintesi Research Srl;Clinical Trials Center Zurich;Cutiss AG

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

05.11.2018

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2017-02079

Secondary ID (Data source: WHO)

TBRU-dS-RAC-PII