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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00324311




Registration number
NCT00324311
Ethics application status
Date submitted
10/05/2006
Date registered
11/05/2006
Date last updated
10/05/2011

Titles & IDs
Public title
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Scientific title
Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
Secondary ID [1] 0 0
MW2004-11-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DGD

Experimental: DGD -

Active Comparator: SOC -


Treatment: Drugs: DGD
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Timepoint [1] 0 0
Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Primary outcome [2] 0 0
Co-primary: % treated wound autografted of deep partial wounds
Timepoint [2] 0 0
Post-debridement autografts
Secondary outcome [1] 0 0
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
Timepoint [1] 0 0
As for primary endpoint
Secondary outcome [2] 0 0
Time to complete wound closure
Timepoint [2] 0 0
% epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Secondary outcome [3] 0 0
Timely eschar removal
Timepoint [3] 0 0
Debridement procedures
Secondary outcome [4] 0 0
Blood loss
Timepoint [4] 0 0
Throughout study

Eligibility
Key inclusion criteria
1. Males and females between 4 years to 55 years of age,

2. Thermal burns caused by fire/flame, scalds or contact,

3. 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,

4. At least one wound of = 2% TBSA deep partial thickness and/or full thickness burn,

5. Total burn wounds = 30% TBSA,

6. Signed written informed consent.
Minimum age
4 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Deep partial thickness and/or full thickness facial burn wounds, > 0.5% TBSA; study
treatment of facial burns is not allowed,

2. 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),

3. Circumferential anterior/posterior trunk full thickness fire/flame burns, > 15% TBSA,
(Circumferential is defined as encircling = 80% of the trunk circumference.)

4. Pre-enrollment escharotomy,

5. Heavily contaminated burns or pre-existing infections,

6. Signs that may indicate smoke inhalation,

7. General condition of patient would contraindicate surgery,

8. Pregnant women (positive pregnancy test) or nursing mothers,

9. Poorly controlled diabetes mellitus (HbA1c>9%),

10. Cardio-pulmonary disease (MI within 4 weeks prior to injury, pulmonary hypertension,
COPD or pre-existing oxygen-dependent pulmonary diseases),

11. Pre-existing diseases which interfere with circulation (PVD, edema, lymphedema,
surgery to the regional lymph nodes, obesity, varicose veins),

12. Immediate life threatening conditions (such as immuno-compromising diseases, life
threatening trauma, severe pre-existing coagulation disorder, cardiovascular, liver or
neoplastic disease),

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Hospital Perth - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Goiania
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
France
State/province [3] 0 0
Marseille
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Ludwigshafen
Country [7] 0 0
Germany
State/province [7] 0 0
Mannheim
Country [8] 0 0
Israel
State/province [8] 0 0
Beer Sheba
Country [9] 0 0
Italy
State/province [9] 0 0
Cesena
Country [10] 0 0
Italy
State/province [10] 0 0
Palermo
Country [11] 0 0
Poland
State/province [11] 0 0
Warsaw
Country [12] 0 0
Romania
State/province [12] 0 0
Bucharest
Country [13] 0 0
Slovakia
State/province [13] 0 0
Bratislava
Country [14] 0 0
Slovakia
State/province [14] 0 0
Kosice-Saca
Country [15] 0 0
United Kingdom
State/province [15] 0 0
East Grinstead
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Wakefield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MediWound Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00324311
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Lior Rosenberg, MD
Address 0 0
MediWound Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries