Brief description of trial (Data source: BASEC)
Diese Studie wird bei Kindern <12 Jahr durchgeführt, die aufgrund einer Hautverbrennung eine Hauttransplantation benötigen. Sie wird in verschiedenen Ländern und Spitälern (Zentren) durchgeführt: Zürich, Schweiz, in Beverwijk, Niederlanden und in Napoli, Italien.
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(Data source: BASEC)
Hautdefekt
Health conditions
(Data source: WHO)
Burns
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: <12 Jahre
• Akute Verbrennung welche 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: <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
- 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 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 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 trial
Date trial registered
Jul 7, 2017
Incorporation of the first participant
Oct 25, 2017
Recruitment status
Recruiting
Academic title
(Data source: 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
(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/Phase 3
Primary end point
(Data source: WHO)
Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
Secundary end point
(Data source: 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
(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)
Christin Roeskes
+41 44 266 33 79
studien.plastische@kispi.uzh.ch
Contact for general information
(Data source: WHO)
Clemens Schiestl, Prof.
University Children's Hospital, Zurich
+41 44 266 73 93
clemens.schiestl@kispi.uzh.ch
Contact for scientific information
(Data source: WHO)
Clemens Schiestl, Prof.
University Children's Hospital, Zurich
+41 44 266 73 93
clemens.schiestl@kispi.uzh.ch
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
05.03.2018
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2017-00969
Secondary ID (Data source: WHO)
TBRU-dS-BC-PIIb
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