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Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries

Studies

Study First Submitted Date 2019-07-26
Study First Posted Date 2019-08-01
Last Update Posted Date 2020-01-09
Verification Month Year January 2020
Verification Date 2020-01-31
Last Update Posted Date 2020-01-09

Detailed Descriptions

Sequence: 20696690
Description This is an Expanded Access (treatment) protocol to allow ongoing treatment of burn patients with NexoBrid following completion of the enrollment stage of protocol MW2010-03-02 (DETECT study).

This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in patients suffering from DPT and FT thermal burns.

Following the enrollment of a patient to the protocol, physicians will identify one or more target wounds (TWs) per patient according to the TW definition. All patient’s DPT and FT burns that comply with the specified entrance criteria will be treated with NexoBrid and, therefore, must be designated as TWs. This will further allow an evaluation of the patient’s systemic safety by allowing treatment of the patient’s entire deep burns.

Prior to initiation of eschar removal treatment, patients will be medicated with appropriate analgesia and undergo wound cleansing and dressing of all wounds with antibacterial solutions according to product instruction for use in order to ensure clean and moist eschar covered wound bed for NexoBrid application. Vital signs (Blood Pressure, Heart Rate and temperature) measurements and pain assessment will be performed within 24 hrs before start of treatment as well as haematology, biochemistry blood tests & PTT/INR. Pressure measurements for circumferential extremity wounds will be performed 1 hour before start of treatment and will be closely monitored during treatment. Following wound cleansing and soaking treatments, patients will undergo the eschar removal process. TWs of up to 15% total body surface area (TBSA) will be treated with a single application of NexoBrid for 4 hours. Patients with TWs >15% TBSA and up to 30% TBSA will be treated with 2 consecutive applications of 4 hours each. NexoBrid should not be applied to more than 15% TBSA in one session. PK samples will be taken from sub-set of patients with TWs area >15% TBSA. Pressure measurements for circumferential extremity wounds will be performed after the removal of NexoBrid.

Post eschar removal completion, patients will undergo daily vital signs (Blood Pressure, Heart Rate and temperature measurements) and pain assessments for 1 week, starting on the morning following start of eschar removal. Blood tests (haematology and biochemistry) will be performed 24 ± 6 hrs post eschar removal as well as PTT/INR. Weekly assessments of wound healing progress including the dressings used until complete wound closure will be performed.

Cosmesis (scar quality) evaluation (using MVSS) will be performed at 3 and 12 months post wound closure confirmation visit.

Facilities

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Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available Status Available
Name University of South Alabama Name Maricopa Medical Center Name Medstar Washington Hospital Center Name University of Florida Name Jackson Memorial Hospital Name The University of Iowa Hospitals and Clinics Name University of Iowa Hospitals and Clinics Name Burnett Burn Center at The University of Kansas Hospital Name Johns Hopkins Burn Center Name The General Hospital Corporation d/b/a Massachusetts General Hospital Name Hennepin Healthcare Name University of Missouri Health Care Name New-York Presbyterian Hospital Name Emergency Medicine Stony Brook University Hospital Name The Oregon Clinic Name Lehigh Valley Hospital and Health Network Name Firefighters Regional Burn Center Name University of Utah Hospital Name Harborview Medical Center Name Colombia St Mary’s, Inc.
City Mobile City Phoenix City Washington City Gainesville City Miami City Iowa City City Iowa City City Kansas City City Baltimore City Boston City Minneapolis City Columbia City New York City Stony Brook City Portland City Allentown City Memphis City Salt Lake City City Seattle City Milwaukee
State Alabama State Arizona State District of Columbia State Florida State Florida State Iowa State Iowa State Kansas State Maryland State Massachusetts State Minnesota State Missouri State New York State New York State Oregon State Pennsylvania State Tennessee State Utah State Washington State Wisconsin
Zip 36617 Zip 85008 Zip 20010 Zip 32610 Zip 33136 Zip 52242 Zip 52242 Zip 66160 Zip 21287 Zip 02114 Zip 55415 Zip 65212 Zip 10065 Zip 11794 Zip 972227 Zip 18103 Zip 38103 Zip 84132 Zip 98104 Zip 53211
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States

Facility Contacts

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Facility Id 199783451 Facility Id 199783451 Facility Id 199783452 Facility Id 199783452 Facility Id 199783453 Facility Id 199783453 Facility Id 199783454 Facility Id 199783454 Facility Id 199783455 Facility Id 199783455 Facility Id 199783456 Facility Id 199783456 Facility Id 199783457 Facility Id 199783458 Facility Id 199783458 Facility Id 199783459 Facility Id 199783459 Facility Id 199783460 Facility Id 199783460 Facility Id 199783461 Facility Id 199783461 Facility Id 199783462 Facility Id 199783462 Facility Id 199783463 Facility Id 199783463 Facility Id 199783464 Facility Id 199783464 Facility Id 199783465 Facility Id 199783466 Facility Id 199783466 Facility Id 199783467 Facility Id 199783468 Facility Id 199783468 Facility Id 199783469 Facility Id 199783469 Facility Id 199783470 Facility Id 199783470
Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup
Name Andrew Bright, DO Name Kelley Prutzman, RN Name Kevin Foster, MD Name Suzanne Osborne, RN Name Jeffrey Shupp, MD Name Melissa McLawhorn Name Joshua Carson, MD Name Tera Thigpin Name Louis Pizano, MD Name Ron Manning Name lucy wibbenmeyer, MD Name Elizabeth Morgan Name Lucy Wibbenmeyer, MD Name Dhaval Bhavsar, MD Name Jessica Reynolds, RN Name Julie Caffrey, MD Name Vidhi Javia Name Jeremy Goverman, MD Name Jennifer Levin, RN Name Frederick Endorf, MD Name Emily Kittelson Name Jeffrey Litt, DO Name Jennifer Randolph, RN Name James Gallagher, MD Name Angela Rabbitts, RN Name Adam Singer, Dr Name Maria (Merry) Taylor, RN Name Kristin Hickey Name Sigrid Blome-Eberwein, MD Name Mary Sobotor, CCRC Name William Hickerson, MD Name Giavonni Lewis, MD Name Martin Carricaburu Name Tam Pham, MD Name Emily Eschelbach, RN Name Nicholas Meyer, MD Name Margaret Wilson
Email abright@health.southalabama.edu Email kevin_foster@dmgaz.org Email suzanne.osborn@mihs.org Email jeffrey.w.shupp@medstar.net Email Melissa.M.Mclawhorn@medstar.net Email Joshua.Carson@surgery.ufl.edu Email tera.thigpin@surgery.ufl.edu Email lpizano@med.miami.edu Email rmanning@med.miami.edu Email lucy-wibbenmeyer@uiowa.edu Email elizabeth-morgan@uiowa.edu Email lucy-wibbenmeyer@uiowa.edu Email dbhavsar@kumc.edu Email jreynolds11@kumc.edu Email jcaffre5@jhmi.edu Email vjavia1@jhmi.edu Email JGOVERMAN@mgh.harvard.edu Email Jlevin7@partners.org Email Frederick.Endorf@hcmed.org Email Emily.Kittelson@hcmed.org Email littjs@health.missouri.edu Email randolphjl@health.missouri.edu Email jag9027@med.cornell.edu Email anr2002@med.cornell.edu Email adam.singer@stonybrookmedicine.edu Email PhaMaria.Taylor@stonybrookmedicine.edu Email Sigri.Blome-Eberwein@lvhn.org Email Mary.Sobotor@lvhn.org Email whicker@uthsc.edu Email giavonni.lewis@hsc.utah.edu Email martin.carricaburu@hsc.utah.edu Email tpham94@uw.edu Email eschee13@uw.edu Email whicker@uthsc.edu Email Margaret.Wilson2@ascension.org
Phone 251-471-7971 Phone 602-344-5624 Phone 602-344-5141 Phone 202-877-7347 Phone 202-877-6181 Phone 352-265-0111 Phone 305-585-1178 Phone 305-355-4990 Phone 319-356-3551 Phone 319-356-1304 Phone 319-356-1304 Phone 913-588-2000 Phone 913-588-0068 Phone 443-287-7848 Phone 617-726-3712 Phone 612-873-6396 Phone 573-884-6779 Phone 573-882-4387 Phone 212-746-7913 Phone 212-746-5881 Phone 631-444-7857 Phone 631-444-8345 Phone 503-413-5447 Phone 610-402-1485 Phone 610-402-1592 Phone 901-448-2579 Phone 801-581-8990 Phone 801-581-3363 Phone 206-744-3140 Phone 206-744-3587 Phone 414-585-1498

Facility Investigators

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Facility Id 199783451 Facility Id 199783452 Facility Id 199783453 Facility Id 199783454 Facility Id 199783455 Facility Id 199783456 Facility Id 199783458 Facility Id 199783459 Facility Id 199783460 Facility Id 199783461 Facility Id 199783462 Facility Id 199783463 Facility Id 199783464 Facility Id 199783465 Facility Id 199783466 Facility Id 199783467 Facility Id 199783468 Facility Id 199783469 Facility Id 199783470
Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator Role Principal Investigator
Name Andrew Bright, DO Name Kevin Foster, MD Name Jeffrey Shupp, MD Name Joshua Carson, MD Name Louis Pizano, MD Name lucy wibbenmeyer, MD Name Dhaval Bhavsar, MD Name Julie Caffrey, MD Name Jeremy Goverman, MD Name Frederick Endorf, MD Name Jeffrey Litt, MO Name James Gallagher, MD Name Adam Singer, MD Name Michael J Mosier, MD Name Sigrid Blome-Eberwein, MD Name William Hickerson, MD Name Giavonni Lewis, MD Name Tam Pham, MD Name Nicholas Meyer, MD

Conditions

Sequence: 52103752
Name Thermal Burn
Downcase Name thermal burn

Id Information

Sequence: 40105794
Id Source org_study_id
Id Value MW2018-06-21

Countries

Sequence: 42508321
Name United States
Removed False

Interventions

Sequence: 52417776
Intervention Type Drug
Name NexoBrid
Description NexoBrid is presented as lyophilized powder and gel vehicle for preparation of a gel for cutaneous use. The API is a concentrate of proteolytic enzymes enriched in Bromelain extracted from the stem of Ananas comosus (pineapple plant)

Browse Conditions

Sequence: 193222013 Sequence: 193222014
Mesh Term Burns Mesh Term Wounds and Injuries
Downcase Mesh Term burns Downcase Mesh Term wounds and injuries
Mesh Type mesh-list Mesh Type mesh-ancestor

Sponsors

Sequence: 48257494
Agency Class INDUSTRY
Lead Or Collaborator lead
Name MediWound Ltd

Central Contacts

Sequence: 11994290 Sequence: 11994291
Contact Type primary Contact Type backup
Name Limor Klein, PhD Name Keren David-Zarbiv
Phone 972-77-9714176 Phone 972-77-9714103
Email limord@mediwound.com Email kerend@mediwound.com
Role Contact Role Contact

Eligibilities

Sequence: 30726827
Gender All
Minimum Age 18 Years
Maximum Age N/A
Criteria Inclusion Criteria patient level:

Males and females ≥ 18 years of age,
Thermal burns caused by fire/flame, scalds or contact,
Patient total burns area ≥ 1% DPT and / or FT with eschar that should be removed in SOC,
Patient total burns area to be treated should be ≤ 30% TBSA; SPT, DPT and/or FT in depth,
Informed consent can be obtained within 84h of the burn injury,

Patients who are willing and able to sign a written consent . Inclusion Criteria – Wound level

At least one wound (a continuous burn area) that is ≥0.5% TBSA (DPT and/or FT) (this minimal wound size should not include face, perineal or genital)

All planned TWs should meet the following criteria:

SPT areas that cannot be demarcated from DPT and FT areas should be less than 50% of the % TBSA of the TW, with eschar that should be removed in SOC,
Wound’s blisters can be removed/ unroofed, as judged by the investigator.

Exclusion Criteria patient level:

Modified Baux index ≥ 80,
Patients with burned, charred fingers, 3rd degree in depth and possibly devoid of circulation,
Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid),
Patients with pre enrolment escharotomy,
Patients with electrical or chemical burns,
The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
Patients with pre-enrolment wounds which are covered by eschar heavily saturated with Silver, Iodine or by SSD pseudoeschar (pseudoeschar as a result of > 12 hrs SSD treatment),
Patients with diagnosed infections as described in the protocol,
Diagnosis of smoke inhalation injury [12],
Pregnant women (serum positive pregnancy test) or nursing mothers,
Poorly controlled diabetes mellitus (HbA1c>11%) in patients with known diabetes as captured in the medical history,
BMI greater than 39.0 kg/m2 in patients with burns area of up to 15% TBSA or BMI greater than 34.0 kg/m2 in patients with burns area of more than 15% %TBSA,
American Society of Anesthesiologists (ASA) physical status classification system greater than 2
Cardio-pulmonary disease (MI within 6 months prior to injury, severe or unstable Ischemic Heart Disease, severe or unstable heart failure, severe pulmonary hypertension, severe COPD or pre-existing oxygen-dependent pulmonary diseases, severe broncho-pneumonia within 1 month prior to injury, steroid dependent asthma or uncontrolled asthma),
Pre-existing diseases which interfere with circulation (severe peripheral vascular disease, severe circulatory edema and/or lymphedema, regional lymph nodes dissection, significant varicose veins),
Any conditions that would preclude safe treatment or adding further risk to the basic acute burn trauma (such as severe immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, severe cardiovascular disorder, significant pulmonary disorder, significant liver disorder including post alcoholic abuse impaired function or neoplastic disease, blast injury),
Chronic systemic steroid intake,
History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain.

Enrollment in any investigational drug trial within 4 weeks prior to screening.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253978210
Number Of Facilities 20
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years

Responsible Parties

Sequence: 28839680
Responsible Party Type Sponsor