Back to resultsEnzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Primary Purpose
Burn
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DGD
Sponsored by
About this trial
This is an interventional treatment trial for Burn
Eligibility Criteria
Inclusion Criteria: Males and females between 4 years to 55 years of age, Thermal burns caused by fire/flame, scalds or contact, Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds ≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment, At least one wound of ≥ 2% TBSA deep partial thickness and/or full thickness burn, Total burn wounds ≤ 30% TBSA, Signed written informed consent. Exclusion Criteria: Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA; study treatment of facial burns is not allowed, Study treatment of perineal and/or genital burns (A patient with these wounds may be enrolled but the wounds may not be designated as target wounds), Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling ≥ 80% of the trunk circumference.) Pre-enrollment escharotomy, Heavily contaminated burns or pre-existing infections, Signs that may indicate smoke inhalation, General condition of patient would contraindicate surgery, Pregnant women (positive pregnancy test) or nursing mothers, Poorly controlled diabetes mellitus (HbA1c>9%), Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases), Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins), Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),
Sites / Locations
- Royal Hospital Perth
- Pronto Socorro para Queimaduras de Goiania
- Hospital do Servidor Publico do Estado de Sao Paulo
- Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
- Center Des Brules Hopital Cochin
- Unfallkrankenhaus Berlin Burn Center
- BG - Unfallklinik Ludwigshafen
- Klinikum Mannheim Universtatsklinikum
- Soroka University Medical Center
- Centro Grandi Ustionati
- Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico
- Wojskowy Instytut Medyczny
- Emergency Clinic Hospital "Bagdazar-Arsenie"
- Center for Burns & Reconstructive Surgery, University Hopsital Bratislava
- Clinic of Burns and Reconstructive Surgery Hospital Kosice
- Queen Victoria Hospital
- The Burn Center Pinderfields Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DGD
SOC
Arm Description
Outcomes
Primary Outcome Measures
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Co-primary: % treated wound autografted of deep partial wounds
Secondary Outcome Measures
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
Time to complete wound closure
Timely eschar removal
Blood loss
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00324311
Brief Title
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Official Title
Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MediWound Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Burns represent one of the most severe and dreaded traumas. Burned and traumatized tissue is known as eschar. The dead eschar, if not removed, often becomes heavily contaminated and is the source of local and/or systemic infection or sepsis. The local inflammation and infection destroy healthy surrounding tissues and extends the original damage. In order to prevent these complications, and in order to minimize the risk of infection, it is imperative to evaluate the burn and remove all of the offending eschar at the earliest possible opportunity. This removal of dead tissue is termed "debridement".
The most direct debridement method for eschar removal is surgery. Traditional, conservative non-surgical debridement is a lengthy process which often involves many complications.
The objective of this study is to evaluate the safety and enzymatic debriding efficacy of Debrase Gel Dressing (DGD) in hospitalized patients with deep partial thickness and/or full thickness thermal burns and to compare DGD to standard of care (SOC).
Detailed Description
Completed study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DGD
Arm Type
Experimental
Arm Title
SOC
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DGD
Intervention Description
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
Primary Outcome Measure Information:
Title
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Time Frame
Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Title
Co-primary: % treated wound autografted of deep partial wounds
Time Frame
Post-debridement autografts
Secondary Outcome Measure Information:
Title
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
Time Frame
As for primary endpoint
Title
Time to complete wound closure
Time Frame
% epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Title
Timely eschar removal
Time Frame
Debridement procedures
Title
Blood loss
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females between 4 years to 55 years of age,
Thermal burns caused by fire/flame, scalds or contact,
Deep partial thickness (mixed deep dermal) and/or full thickness (3°) burn wounds ≥ 5% and ≤ 30% Total Body Surface Area (TBSA); all these wounds must receive study treatment,
At least one wound of ≥ 2% TBSA deep partial thickness and/or full thickness burn,
Total burn wounds ≤ 30% TBSA,
Signed written informed consent.
Exclusion Criteria:
Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA; study treatment of facial burns is not allowed,
Study treatment of perineal and/or genital burns (A patient with these wounds may be enrolled but the wounds may not be designated as target wounds),
Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA, (Circumferential is defined as encircling ≥ 80% of the trunk circumference.)
Pre-enrollment escharotomy,
Heavily contaminated burns or pre-existing infections,
Signs that may indicate smoke inhalation,
General condition of patient would contraindicate surgery,
Pregnant women (positive pregnancy test) or nursing mothers,
Poorly controlled diabetes mellitus (HbA1c>9%),
Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases),
Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema, surgery to the regional lymph nodes, obesity, varicose veins),
Immediate life threatening conditions (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or neoplastic disease),
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lior Rosenberg, MD
Organizational Affiliation
MediWound Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Hospital Perth
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Pronto Socorro para Queimaduras de Goiania
City
Goiania
Country
Brazil
Facility Name
Hospital do Servidor Publico do Estado de Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Center Des Brules Hopital Cochin
City
Paris
ZIP/Postal Code
F-75014
Country
France
Facility Name
Unfallkrankenhaus Berlin Burn Center
City
Berlin
Country
Germany
Facility Name
BG - Unfallklinik Ludwigshafen
City
Ludwigshafen
Country
Germany
Facility Name
Klinikum Mannheim Universtatsklinikum
City
Mannheim
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer Sheba
Country
Israel
Facility Name
Centro Grandi Ustionati
City
Cesena
ZIP/Postal Code
47023
Country
Italy
Facility Name
Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Wojskowy Instytut Medyczny
City
Warsaw
Country
Poland
Facility Name
Emergency Clinic Hospital "Bagdazar-Arsenie"
City
Bucharest
Country
Romania
Facility Name
Center for Burns & Reconstructive Surgery, University Hopsital Bratislava
City
Bratislava
ZIP/Postal Code
82107
Country
Slovakia
Facility Name
Clinic of Burns and Reconstructive Surgery Hospital Kosice
City
Kosice-Saca
ZIP/Postal Code
04015
Country
Slovakia
Facility Name
Queen Victoria Hospital
City
East Grinstead
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom
Facility Name
The Burn Center Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4EE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15555800
Citation
Rosenberg L, Lapid O, Bogdanov-Berezovsky A, Glesinger R, Krieger Y, Silberstein E, Sagi A, Judkins K, Singer AJ. Safety and efficacy of a proteolytic enzyme for enzymatic burn debridement: a preliminary report. Burns. 2004 Dec;30(8):843-50. doi: 10.1016/j.burns.2004.04.010.
Results Reference
background
PubMed Identifier
24074719
Citation
Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.
Results Reference
derived
Learn more about this trial
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
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