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A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care

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ClinicalTrials.gov Identifier: NCT02278718
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
GCP-Service International Ltd. & Co. KG
Information provided by (Responsible Party):
MediWound Ltd

Brief Summary:
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

Condition or disease Intervention/treatment Phase
Thermal Burns Drug: NexoBrid Procedure: Standard of Care Phase 3

Detailed Description:

A total of 160 patients will be randomized into NexoBrid and SOC treatment (80 patients per arm).

Age distribution will be managed as follows:

  • 40 patients 0-23 months old
  • 40 patients 24 months-3 years old
  • 48 patients 4-11 years old
  • 32 patients 12-17 years old

The study will be conducted in two stages. In Stage I, 50 children age 4-17 years, hospitalized in burn units, with deep partial thickness burns ranging from 1%-30% TBSA, and who meet the entrance criteria, will be enrolled. Upon completion of stage I (once the 50th patient has reached wound closure), an interim analysis will be performed on safety parameters and the results will be blindly evaluated by a Data Safety Monitoring Board (DSMB). If the DSMB does not have any safety concerns, Stage II will commence, this time enrolling children at the aged of 0-17 years according to the study procedures.

Following the enrollment of a subject to the study and prior to randomization, physicians will define one or more Target Wounds (TWs) per subject according to TWs definition. All subjects' DPT and FT burns that fit the specified criteria are intended to receive study treatment per randomized study arm and therefore, must be designated as TWs.

Prior to eschar removal treatment with NexoBrid or SOC subjects will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions. Following wound cleansing and antibacterial treatments, subjects will undergo the eschar removal process as per treatment assignment (NexoBrid or SOC, following randomization). Subsequent to eschar removal, all wounds will be assessed and treated in the same manner, in accordance with post-eschar removal wound care strategy. Furthermore, subjects will undergo daily assessments (Vital signs (VS) and pain assessments) for one week and weekly assessments thereafter, until wound closure. Following wound closure, subjects will be followed up at 6 weeks, 12 weeks, and after that, at 6, 12, 18 and 24 months (for a blinded assessment of cosmesis, function and QoL evaluation).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: NexoBrid Gel
NexoBrid Gel is applied to the burn wound at a dose of 2g or 5g NexoBrid sterile powder mixed with 20g or 50g sterile Gel Vehicle per 180cm^2 of TBSA for four hours.
Drug: NexoBrid
Active Comparator: Standard of Care
Non surgical and Surgical Debridement
Procedure: Standard of Care



Primary Outcome Measures :
  1. Earlier eschar removal (in days) [ Time Frame: participants will be followed from randomization date and daily for the duration of hospital stay, an expected average of 3 weeks ]
    Demonstrate superiority over SOC for eschar removal as measured by a survival analysis of incidence of complete eschar removal as a function of time. Eschar removal will be measured at the end of the debridement starting from randomization date.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Stage 1: Males and females between 4 years to 17 years of age, Stage 2 (upon approval of DSMB): Males and females between 0 years to 17 years of age.
  2. Thermal burns caused by fire/flame, scalds or contact.
  3. Patient total burns area should be between 1% to 30% TBSA (≥ 1% and ≤ 30% ; SPT, DPT and/or FT in depth),
  4. Signed written informed consent by a legal guardian can be obtained within 72 hours of the burn injury.

At least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:

  1. Wound that is ≥ 1% TBSA (not including face, perineal or genital),
  2. Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,
  3. Wound that is intended for surgical eschar removal,
  4. Wound's blisters can be unroofed, as judged by the investigator.

Exclusion Criteria:

  1. Patients who are unable to follow study procedures and follow up period,
  2. Patients with electrical or chemical burns,
  3. Patient with a continuous burn area above 15% TBSA,
  4. Patients with no DPT and/or FT burn area (only SPT wounds),
  5. DPT and/or FT facial burn wounds from flame, flash, explosion >0.5% TBSA (scald and contact burns are allowed); study treatment of all facial burns is not allowed,
  6. Study treatment of perineal and/or genital burns is not allowed; however, a patient with these wounds may be enrolled but the wounds may not be designated as target wounds,
  7. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling ≥ 80% of the trunk circumference),
  8. The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
  9. Patients with diagnosed infections as described in Section 13.2.5 of study protocol,
  10. Any signs or history that may indicate smoke inhalation (e.g. flames in enclosed spaces, smoke and fumes on the patient and in mouth and nostrils, deep flame burns >0.5 %TBSA to the face, cough, hoarseness, stridor or breathing difficulty including tachypnea possibly related to smoke inhalation, etc.),
  11. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
  12. Patients with pre-enrolment escharotomy,
  13. Pregnant women (positive pregnancy test) or nursing mothers,
  14. Poorly controlled diabetes mellitus (HbA1c>9%),
  15. Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma),
  16. Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
  17. Any known conditions that would preclude safe participation in the study or add further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),
  18. ASA greater than 2
  19. Chronic systemic steroid intake,
  20. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
  21. Current (within 12 months prior to screening) suicide attempt,prior to screening,
  22. Enrollment in any investigational drug trial within 4 weeks prior to screening,
  23. Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse,
  24. Prisoners and incarcerated
  25. Patients who might depend on the clinical study site or investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278718


Contacts
Contact: Tami Aibester +972-77-971-4168 tamia@mediwound.com
Contact: Keren David-Zarbiv +972-77-9714103 kerend@mediwound.com

Locations
Belgium
University Hospital, Department of Plastic Surgery Recruiting
Gent, Belgium, B 9000
Contact: Prof. Dr. Stan J. Monstrey    0032-(0) 9-332 2220    stan.monstrey@UGENT.be   
Bulgaria
UMHATEM N.I.Pirogov Recruiting
Sofia, Bulgaria, 1606
Contact: Dr. Prof. Ognyan Hadzhiyski    00359 2 9526690    burns_hadj@hotmail.com   
France
Hôpital Pellegrin - Tripode Recruiting
Bordeaux cedex, France, 33076
Contact: Pr. Vincent Casoli    00 33 (0)5 56 79 56 79    vincent.casoli@chu-bordeaux.fr   
Hôpital Nord Recruiting
Marseille, France, 13015
Contact: Dr. Renaud Vialet    0033(0)4 91 96 86 68    renaud.vialet@ap-hm.fr   
Service de Chirurgie Plastique, Centre des Brûlés Recruiting
Nantes cedex, France, 44093
Contact: Pr. Franck Duteille    02 40 08 37 12    pierre.perrot@chu-nantes.fr   
Germany
Unfallkrankenhaus Berlin Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie Recruiting
Berlin, Germany, 12683
Contact: Dr. Bernd Hartmann    030 5681 3501    bernd.hartmann@ukb.de   
AKK Altonaer Kinderkrankenhaus Recruiting
Hamburg, Germany, D- 22763
Contact: Dr. med. Ingo Königs    +49 40 88908- 230    ingo.koenigs@kinderkrankenhaus.de   
Klinikum Nürnberg Kinderchirurgie Recruiting
Nürnberg, Germany, 90471
Contact: Dr. Karl Bodenschatz         
Contact    0911 398-5455    karl.bodenschatz@klinikum-nuernberg.de   
Klinikum Stuttgart - Olgahospital Recruiting
Stuttgart, Germany, D-70176
Contact: Dr. Torsten Hannmann    +49 711 2787 3625    t.hanmann@klinikum-stuttgart.de   
Israel
Rambam Healthcare Campus Recruiting
Haifa, Israel, 3525408
Contact: Dr. Prof.Yehuda Ullmann    +972-4-8542794    y_ullmann@rambam.health.gov.il   
Italy
Ospedale Sant'Eugenio Not yet recruiting
Roma, Italy
Contact: Dr Giancarlo Delli Santi    +393203678544    gdsanti@yahoo.com   
Netherlands
Acute Burn Care &Trauma Surgery, Dept Surgery/Burn Center, Rode Kruis Ziekenhuis, LUMC University Leiden Recruiting
Beverwijk, Netherlands, 1942
Contact: Prof. Dr. Rolf Breederveld    0031 251 265555    rbreederveld@rkz.nl   
Romania
Spitalul Clinic de Urgenta pentru Copii, "Grigore Alexandrescu" Recruiting
Bucharest, Romania, 011743
Contact: DR. Prof. Dan Mircea Enescu    +40744355511    enescudr@hotmail.com   
Spitalul Clinic de Urgență pentru Copii Recruiting
Cluj, Romania, 400001
Contact: Dr. Horatiu Gocan    +4 0744500525    horatiugocan@yahoo.com   
Spitalul Clinic de Urgenta pentru Copii "Sfanta Maria" Recruiting
Iasi, Romania, 700309
Contact: Dr. Elena Hanganu    +4 0744709689    dr.elenahanganu@gmail.com   
Spitalul Clinic de Urgenta Tg- Mures Recruiting
Tg-Mures, Romania, 54000
Contact: Dr. Gheorghe Horea Gozar    +4 0740070534    horea_gozar@yahoo.com   
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Recruiting
Timisoara, Romania, 300011
Contact: DR. Sorin Eugen Boia    +4 0732890553    boiaeugen@yahoo.com   
Slovakia
Univerzitná nemocnica Bratislava, Klinika popálenin a rekonštrukčnej chirurgie Recruiting
Bratislava, Slovakia, 826 06
Contact: Dr. Ján Koller    +421(2)48234527    koller@ru.unb.sk   
Klinika popálenin a rekonštrukčnej chirurgie, Nemocnica Košice-Šaca a.s. Recruiting
Košice-Šaca, Slovakia, 040 15
Contact: Dr. Prof. Peter Lengyel    00421911500551    plengyel@nemocnicasaca.sk   
Spain
Vall d'Hebron Institut de Recerca (VHIR) Recruiting
Barcelona, Spain, 08035
Contact: Dr. Ricardo Palao    +34 629 33 01 02    rpalao@vhebron.net   
La Paz University Hospital Recruiting
Madrid, Spain, 28046
Contact: Dr. Juan Carlos López Gutierrez    +34 639 20 38 67    queminfantil.hulp@salud.madrid.org   
Boulevar Sur s/n Recruiting
Valencia, Spain, 46026
Contact: Dr. Patricia Gutierrez Ontalvilla    +34 669 88 49 28    patricia@dragutierrez.com   
Aragonese Institute of Health Sciences Not yet recruiting
Zaragoza, Spain, 50009
Contact: Dr. Enrique Monclús Fuertes    +34 607 476 794    doctorenriquemonclus@gmail.com   
Sweden
Brännskadecentrum, VO Plastikkirurgi och Käkkirurgi, Akademiska sjukhuset Recruiting
Uppsala, Sweden, 751 85
Contact: Prof. Dr. Fredrik Huss    +46 70 7941 574    fredrik.huss@akademiska.se   
United Kingdom
Queen Victoria Hospital Recruiting
East Grinstead, West Sussex, United Kingdom, RH19 3DZ
Contact: Dr. Baljit Dheansa    0044 1342 4140 24    Baljit.Dheansa@QVH.nhs.uk   
Birmingham Children´s Hospital NHS Foundation Trust Not yet recruiting
Birmingham, United Kingdom
Contact: Dr. Yvonne Wilson    +44 121 333 8964      
Sponsors and Collaborators
MediWound Ltd
GCP-Service International Ltd. & Co. KG
Investigators
Study Chair: Lior Rosenberg, Prof. MediWound Ltd
Study Director: Yaron Shoham, Dr. MediWound Ltd

Additional Information:
Publications:
Responsible Party: MediWound Ltd
ClinicalTrials.gov Identifier: NCT02278718     History of Changes
Other Study ID Numbers: MW2012-01-01
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Burns
Wounds and Injuries