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NCT03229564 | SNCTP000002791

Randomisierte, kontrollierte, multinationale, multizentrische Phase IIb Studie zur Überprüfung der Wirksamkeit und Sicherheit von einem Hautersatzprodukt (EHSG-KF) zur Behandlung von grossflächigen und vollständigen Hautdefekten bei Kindern im Vergleich zur 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 Kindern ab 1 Jahr durchgeführt, die aufgrund einer Hautverbrennung eine Hauttransplantation benötigen. Sie wird in verschiedenen Ländern und Spitälern (Zentren) durchgeführt: Kinderspital Zürich, Schweiz; Rotes Kreuz Krankenhaus in Beverwijk, Niederlanden; Universitätsspital in
Birmingham, Grossbritannien.
Es werden zwei verbrannte Hautflächen ausgewählt und gemäss einer Zufallsverteilung wird eine Hautfläche mit EHSG-KF und die andere mit der Eigenhaut versorgt. Während den 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. Das EHSG-KF wurde bisher schon bei Menschen (kleine Anzahl von
Patienten) und Tieren getestet. Wir möchten insgesamt 12 Patienten einschliessen, davon ungefähr 4 im Kinderspital Zürich.
Diese Studie umfasst 12 Visiten während 3 Jahren: 2 vor der Verpflanzung, die
Verpflanzung, 7 Kontrollvisiten innerhalb des ersten Jahres, 2 Langzeitvisiten (1x pro Jahr).

Health conditions investigated (Source of data: BASEC)

Hautdefekt

Health conditions (Source of data: WHO)

Burns

Rare disease (Source of data: BASEC)

Yes

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 -17 Jahre
• Akute Verbrennung welche 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: 1-17 years of age

- Deep partial thickness and/or full-thickness burns requiring surgical wound coverage

- Expected that =90cm2 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

- >25% TBSA burn

- 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 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 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03229564

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03229564

Further information on trial

Date trial registered

07.07.2017

Incorporation of the first participant

25.10.2017

Recruitment status

Recruiting

Academic title (Source of data: WHO)

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)

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/Phase 3

Primary end point (Source of data: WHO)

Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface

Secundary end point (Source of data: WHO)

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

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 MD
University of Zurich, Switzerland
+41 44 266 74 13
clemens.schiestl@kispi.uzh.ch

Contact for scientific information (Source of data: WHO)

Ernst Reichmann, Prof.;Clemens Schiestl, PD MD
University of Zurich, Switzerland
+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)

2017-00969

Secondary ID (Source of data: WHO)

TBRU-dS-BC-PIIb