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Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00324311
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : May 10, 2011
Sponsor:
Information provided by:
MediWound Ltd

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).


Condition or disease Intervention/treatment Phase
Burn Drug: DGD Phase 3

Detailed Description:
Completed study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
Study Start Date : December 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: DGD Drug: DGD
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

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




Primary Outcome Measures :
  1. 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) ]
  2. Co-primary: % treated wound autografted of deep partial wounds [ Time Frame: Post-debridement autografts ]

Secondary Outcome Measures :
  1. % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds [ Time Frame: As for primary endpoint ]
  2. Time to complete wound closure [ Time Frame: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed ]
  3. Timely eschar removal [ Time Frame: Debridement procedures ]
  4. Blood loss [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324311


Locations
Show Show 17 study locations
Sponsors and Collaborators
MediWound Ltd
Investigators
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Study Chair: Lior Rosenberg, MD MediWound Ltd
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Siyu Liu, Vice President, North American Innovative Research & Development and Head of Global Clinical Operations ), Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00324311    
Other Study ID Numbers: MW2004-11-02
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: July 2009
Additional relevant MeSH terms:
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Burns
Wounds and Injuries