Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care - Full Text View

Sponsor:	MediWound Ltd
Information provided by:	MediWound Ltd
ClinicalTrials.gov Identifier:	NCT00324311

Purpose

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).

Condition	Intervention	Phase
Burn	Drug: DGD	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

Resource links provided by NLM:

MedlinePlus related topics: Burns Surgery

U.S. FDA Resources

Further study details as provided by MediWound Ltd:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Co-primary: % treated wound autografted of deep partial wounds [ Time Frame: Post-debridement autografts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds [ Time Frame: As for primary endpoint ] [ Designated as safety issue: No ]
Time to complete wound closure [ Time Frame: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed ] [ Designated as safety issue: No ]
Timely eschar removal [ Time Frame: Debridement procedures ] [ Designated as safety issue: No ]
Blood loss [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	270
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DGD: Experimental	Drug: DGD Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
SOC: Active Comparator	Drug: DGD Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

Detailed Description:

Ongoing study, recruiting adults and children.

Eligibility

Ages Eligible for Study:	4 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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),

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324311

Contacts

Contact: Ronit Koren, PhD	972-8-9324003	ronitk@mediwound.co.il
Contact: Linda Gerstl, BSc	972-8-9324009	lindag@mediwound.co.il

Show 30 Study Locations

Sponsors and Collaborators

MediWound Ltd

Investigators

Study Chair:

Lior Rosenberg, MD

MediWound Ltd

More Information

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.

Responsible Party:	Teva Neuroscience ( Siyu Liu, Vice President, North American Innovative Research & Development and Head of Global Clinical Operations ) )
Study ID Numbers:	MW2004-11-02
Study First Received:	May 10, 2006
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00324311 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on February 08, 2010