A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

Description

This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over SOC and over the Gel Vehicle placebo control treatment in thermal burn subjects. The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar earlier and reducing surgical needs in hospitalized subjects with large burns ( 4-15% of Total Body Surface Area). physicians will define one or more Target Wounds (TWs) per subject according to TWs definition. All subjects' deep (DPT and FT) burns that comply with the specified entrance criteria are intended to receive study treatment per the randomized study arm. The randomization procedure will be initiated only after all Target wounds of a subject have been defined. Patients will be assigned to the treatment arm in a 3:3:1 ratio (NexoBrid: SOC (Collagenase): Gel Vehicle). Prior to eschar removal treatment with NexoBrid, Collagenase (SOC) or Gel Vehicle, patients 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. Eschar Removal with NexoBrid, Gel Vehicle and Collagenase will be performed will be performed by two different health care professionals. First, a health care professional will prepare and apply the topical treatment. Wound assessment will be performed by a different health care professional, masked to the application process and the applied product, after the topical agent has been removed and the wound has been soaked for 2 hours (eliminating all traces of the debriding agent). If medically judged, the same product may be applied for a second time to the same burn area however, not more than twice to the same burn wound area. Additional surgical and/or non surgical procedures, pre defined in the protocol, might be performed, if medically warranted. Subsequent to eschar removal, all wounds will be assessed and treated in the same manner, in accordance with post-eschar removal wound care strategy. Further, patients will undergo daily assessments of VS and pain assessments until HD and weekly assessments thereafter, until wounds closure. Following wounds closure, patients will be followed up on a monthly basis for 3 months and after that, at 6, 9, 12, 18 and 24 months post complete wound closure for long term outcomes evaluation (including cosmesis, function and QoL evaluation).

Study Start Date

April 2015

Estimated Completion Date

November 2019

Interventions

  • Drug: NexoBrid
  • Drug: Santyl
  • Drug: Gel Vehicle
  • Procedure: Standard of Care (SOC)

Specialties

  • Internal Medicine: Critical Care/Hospitalist
  • Pharmacy: Other Drugs
  • Emergency Medicine: Trauma
  • Physician Assistant: Emergency/Trauma
  • Urgent Care:

MeSH Terms

  • Burns
  • NexoBrid
  • Thermal Burns

Study ID

MediWound Ltd -- MW 2010-03-02

Status

Unknown

Trial ID

NCT02148705

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

175

Sponsor

MediWound Ltd

Inclusion Criteria

    1. Males and females ? 18 and ? 70 years of age, 2. Thermal burns caused by fire/flame, scalds or contact, 3. Patient total burns area should be between 4% to 15% TBSA (? 4% and ? 15% SPT, DPT and/or FT in depth), 4. Informed consent can be obtained within 48 hours of the burn injury. 5. Patients who are willing and able to sign a written consent form. Inclusion Criteria
  • Wound level 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. Modified Baux index ? 80, 3. Patients with burned, charred fingers, 3rd degree in depth, possibly devoid of circulation, 4. Patients with > 15% TBSA burns, 5. Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid or Collagenase) will be excluded from the study, 6. Patients with electrical or chemical burns, 7. Patients with DPT and/or FT facial burn wounds from flame, flash, explosion >0.5% TBSA (scald and contact burns are allowed), 8. Patients with circumferential DPT and/or FT burns defined as Extremities at Risk (EAR) , 9. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3), 10. 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), 11. Patients with pre-enrollment escharotomy, 12. Patients with diagnosed infections as described in Section 11.2.3 of study protocol, 13. Any signs or history that may indicate smoke inhalation (e.g. flame burn to the upper body, flames in enclosed space, 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.), 14. Pregnant women (positive pregnancy test) or nursing mothers, 15. Poorly controlled diabetes mellitus (HbA1c>9%) in patients with known diabetes as captured in the medical history, 16. Patients with BMI greater than 34.0 kg/m2, 17. ASA greater than 2 (see Appendix 15 in study protocol) 18. Cardio-pulmonary disease (MI within 6 months prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma), 19. Pre-existing diseases which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to regional lymph nodes, obesity, varicose veins), 20. Any conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular disorder, pulmonary disorder, liver disorder including post alcoholic abuse impaired function or neoplastic disease), 21. Chronic systemic steroid intake, 22. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain, 23. Current (within 12 months prior to screening) suicide attempt, 24. Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc), 25. Enrollment in any investigational drug trial within 4 weeks prior to screening, 26. Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse , 27. Prisoners and incarcerated.

Gender

Both

Ages

17 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (9)

Study Location Distance Name Phone Email
Emergency Medicine Stony Brook University Hospital - Stony Brook,, New York 22.8 miles Adam Singer Dr 631-444-7857 adam.singer@stonybrookmedicine.edu
Lehigh Valley Hospital and Health Network - Allentown, Pennsylvania 124.2 miles Sigrid BlomeEberwein MD 610-402-9046 Sigri.Blome-Eberwein@lvhn.org
Ohio State University Medical Center - Columbus, Ohio 520.3 miles Larry Jones MD 614-293-5710 Larry.Jones@osumc.edu
George David Peak Memorial Burn Wound Center - Milwaukee, Wisconsin 761.6 miles Nicholas A Meyer 414-323-9516 Nicholas.Meyer@columbia-stmarys.org
Firefighters Regional Burn Center - Memphis, Tennessee 1,004.6 miles William L Hickerson 901-448-2525 bhickerson@me.com
Tampa General Hospital Regional Burn Center - Tampa, Florida 1,058.1 miles David Smith MD 813-844-4133 dsmith3@health.usf.edu
University of Colorado at Denver Teaching - Aurora, Colorado 1,658.2 miles Gordon Lindberg MD 303-724-2727 Gordon.Lindberg@ucdenver.edu
Maricopa Medical Center - Phoenix, Arizona 2,181.0 miles Kevin Foster MD 602-344-5624 kevin_foster@dmgaz.org
University of California Irvine Regional Burn Center - Orange, California 2,477.9 miles Nicole Bernal MD 714-743-1095 bernaln@uci.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.