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

This study has been completed.
Sponsor:
Information provided by:
MediWound Ltd
ClinicalTrials.gov Identifier:
NCT00324311
First received: May 10, 2006
Last updated: May 8, 2011
Last verified: July 2009

May 10, 2006
May 8, 2011
December 2005
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
The primary end point is % treated wound excised (tangential and/or minor excision), in first surgery.
Complete list of historical versions of study NCT00324311 on ClinicalTrials.gov Archive Site
  • % 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 ]
Secondary end points are time to complete wound closure and % treated wound autografted.
Not Provided
Not Provided
 
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

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).

Completed study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn
Drug: DGD
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
  • Experimental: DGD
    Intervention: Drug: DGD
  • Active Comparator: SOC
    Intervention: Drug: DGD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
February 2010
October 2009   (final data collection date for primary outcome measure)

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),
Both
4 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   France,   Germany,   Israel,   Italy,   Poland,   Romania,   Slovakia,   United Kingdom
 
NCT00324311
MW2004-11-02
Yes
Siyu Liu, Vice President, North American Innovative Research & Development and Head of Global Clinical Operations ), Teva Neuroscience
MediWound Ltd
Not Provided
Study Chair: Lior Rosenberg, MD MediWound Ltd
MediWound Ltd
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP