BurnPhase 3NCT00324311
Enzymatic Debridement in Burns Patients: A Comparison to Standard of Care
A Phase 3 study testing DGD in people with Burn, run by MediWound Ltd at 17 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 55 years
- Conditions the study is for
- Burn
- What is being tested?
- DGD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 17 sitesin 10 countries
- Study dates
- Dec 2005to Feb 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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),
Trial locations and contacts
17 sites in 10 countries.
17 sites in 10 countries
Germany3 sites
Unfallkrankenhaus Berlin Burn Center
Berlin
BG - Unfallklinik Ludwigshafen
Ludwigshafen
Klinikum Mannheim Universtatsklinikum
Mannheim
Brazil2 sites
Pronto Socorro para Queimaduras de Goiania
Goiânia
Hospital do Servidor Publico do Estado de Sao Paulo
São Paulo
France2 sites
Centre Hospitalier Regional et Universitaire de Marseille, Service de Chirurgie Plastique Reparatrice et Esthetique
Marseille, 13005
Center Des Brules Hopital Cochin
Paris, F-75014
Italy2 sites
Centro Grandi Ustionati
Cesena, 47023
Direttore U.O. Chirurgia Plastica e Centro Ustioni Ospedale Civico
Palermo, 90127
Slovakia2 sites
Center for Burns & Reconstructive Surgery, University Hopsital Bratislava
Bratislava, 82107
Clinic of Burns and Reconstructive Surgery Hospital Kosice
Kosice-Saca, 04015
United Kingdom2 sites
Queen Victoria Hospital
East Grinstead, RH19 3DZ
The Burn Center Pinderfields Hospital
Wakefield, WF1 4EE
About this study
Official title: 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).
Read the detailed description
Completed study.
- Conditions
- Burn
- Being tested
- DGD
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGDDrug
Lyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application.
| Study group | Role | What they receive |
|---|---|---|
| DGD | Experimental | Not described Receives: Drug: DGD |
| SOC | Active comparator | Not described Receives: Drug: DGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary: % treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, of deep partial wounds
Measured: Surgical excision/dermabrasion performed as initial debridement (surgical SOC group) or as first post-debridement procedure (DGD or non-surgical SOC groups)
Co-primary: % treated wound autografted of deep partial wounds
Measured: Post-debridement autografts
Secondary outcomes (4)
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
Measured: As for primary endpoint
Time to complete wound closure
Measured: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Timely eschar removal
Measured: Debridement procedures
Blood loss
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediWound Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lior Rosenberg, MD, Study chair, MediWound Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324311
- Sponsor's protocol ID
- MW2004-11-02
- Status last verified
- Jul 2009
- First submitted
- 10 May 2006
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.burns.2004.04.010.
PubMed 15555800Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.
PubMed 38837237Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.
PubMed 24074719
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enzymatic Debridement in Burns Patients (Children & Adults): A Comparison to Standard of Care (Protocol MW 2004-11-02)
- ClinicalTrials.gov ID
- NCT00324311
- Acronym / sponsor ID
- MW2004-11-02
- Conditions
- Burn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- MediWound LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DGD | Experimental | Drug: DGD |
| SOC | Active comparator | Drug: DGD |
Who may qualify
- Ages
- 4 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DGDLyophilized, sterile mixture of proteolyzed enzymes; mixed with gel,for topical application. | Drug | DGD, SOC |
Primary outcome
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)
Co-primary: % treated wound autografted of deep partial wounds
Time frame: Post-debridement autografts
4 secondary outcomes
% treated wound excised (by tangential/minor/Versajet excision) or dermabrasion, in first surgery, for all wounds
Time frame: As for primary endpoint
Time to complete wound closure
Time frame: % epithelialization assessed post-debridement at weekly intervals until all a patient's wounds closed
Timely eschar removal
Time frame: Debridement procedures
Blood loss
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Background: PubMed 15555800Rosenberg 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. doi: 10.1016/j.burns.2004.04.010.
- Derived from this study: PubMed 38837237Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.
- Derived from this study: PubMed 24074719Rosenberg L, Krieger Y, Bogdanov-Berezovski A, Silberstein E, Shoham Y, Singer AJ. A novel rapid and selective enzymatic debridement agent for burn wound management: a multi-center RCT. Burns. 2014 May;40(3):466-74. doi: 10.1016/j.burns.2013.08.013. Epub 2013 Sep 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lior Rosenberg, MD study chair
MediWound Ltd
17 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DGD in people with Burn, run by MediWound Ltd at 17 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Brazil, France, Italy, Slovakia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00324311, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.