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NCT03394612 | SNCTP000003493

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 Kinder im Vergleich zu autologen Spalthaut-Hauttransplantaten (STSG).

Data source: BASEC (Imported from 24.05.2020), WHO (Imported from 22.03.2020)
Changed: 22.05.2020
Disease category: Haut- und Bindegewebekrankheiten (nicht Krebs)

Brief description of trial (Source of data: 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; Universitätsspital in Birmingham, Grossbritannien.
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 (Source of data: BASEC)

Hautdefekt

Health conditions (Source of data: WHO)

Skin Wound

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Transplantation von Hautersatzprodukt auf Hautdefekt

Interventions (Source of data: WHO)

Biological: EHSG-KF;Biological: STSG

Criteria for participation in trial (Source of data: BASEC)

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

Exclusion criteria (Source of data: 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 (Source of data: 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 (Source of data: 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 (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

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

Phase (Source of data: WHO)

Phase 2

Primary end point (Source of data: WHO)

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

Secundary end point (Source of data: 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.

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Zürich

Countries (Source of data: WHO)

Netherlands, Switzerland, United Kingdom

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

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

Contact for general information (Source of data: WHO)

Ernst Reichmann, Prof.;Clemens Schiestl, PD Dr.
University of Zurich
+41 44 266 74 13
clemens.schiestl@kispi.uzh.ch

Contact for scientific information (Source of data: WHO)

Ernst Reichmann, Prof.;Clemens Schiestl, PD Dr.
University of Zurich
+41 44 266 74 13
clemens.schiestl@kispi.uzh.ch

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

University of Zurich

Additional sponsors (Source of data : WHO)

ETH Zurich (Switzerland);Julius Clinical, The Netherlands

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2017-02079

Secondary ID (Source of data: WHO)

TBRU-dS-RAC-PII