NCT00324311

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: MediWound Ltd · Industry
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Completed study.

Conditions

• Burn

Interventions

Type	Name	Description
DRUG	DGD	Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-10-01
• Completion: 2010-02-01
• First posted: 2006-05-11
• Last updated: 2011-05-10

Locations

17 sites across 10 countries: Australia, Brazil, France, Germany, Israel, Italy, Poland, Romania, Slovakia, United Kingdom