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Completed

NCT Number: NCT00324311

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

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).

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

4 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Hospital Perth, Perth, Western Australia, Australia

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About this study

Completed study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

DGD

Drug

Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MediWound Ltd

Industry

Registry information

Official study title

Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
May 11, 2006
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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