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BurnPhase 2NCT00898521

Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns

A Phase 2 study testing DGD in people with Burn, run by MediWound Ltd at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
36 participants
Where
2 sitesin 2 countries
Study dates
20 Dec 2009to 2 Dec 2015
Phase
Phase 2
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 2 years and 55 years of age,
  • Thermal burns caused by fire/flame, scalds or contact,
  • Burn composition must be as follows:
  • Partial Thickness (mid \& deep dermal) burn wounds ≥ 4% and ≤ 30% Total Body Surface Area (TBSA),
  • Full thickness burns ≤ 5%,
  • All the partial and full thickness burn wounds must receive study treatment except facial, genital or perineal burns (Exclusion Criteria #5 and #6 below),
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  • Total burn wounds ≤ 30% TBSA,
  • Hospital admission within 24 hours of the burn injury. Patients transferred from another hospital/clinic may be enrolled if the primary admission was within 24 hours of the burn injury and admission to the burn unit participating in the study was within 48 hours of the burn injury,
  • Signed written informed consent.

Who cannot join

  • More than 5% TBSA full thickness burns,
  • Patient having only full thickness burns,
  • Other severe cutaneous trauma at the same sites as the burns (i.e. considerable blunt, avulsion or deep abrasion), or previous burn(s) at the same treatment site(s),
  • One or more burn wounds that do not meet study 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 is not allowed; A patient with these wounds may be enrolled but the wounds may not be designated as target wounds,
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  • Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA Circumferential is defined as encircling ≥ 80% of the trunk circumference),
  • A. The following pre enrolment dressings: a. Flammacerium, b. Silver Nitrate AgNO3), B. Pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by pseudoeschar (e.g. pseudoeschar as a result of SSD treatment);
  • Pre-enrolment escharotomy,
  • Heavily contaminated burns or pre-existing infections (Adults: WBC ≥ 20.0 X 103 cells/µL; Children aged 4-18: WBC ≥ 25.0 X 103 cells/µL)),11.Signs that may indicate smoke inhalation (e.g. clinical signs, etiology of injury, venue of injury, etc.),
  • Children with Hb < 10 gm/dl at Screening/Pre treatment
  • Prisoners,
  • 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),
  • Chronic systemic steroid intake,
  • History of allergy and/or known sensitivity to pineapples or papain,
  • Current suicide attempt,
  • Participation in another investigational drug trial,
  • Current alcohol or drug abuse,

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

India1 site

  • Lok Nayak hospital

    New Delhi

Other trials in India

Israel1 site

  • Soroka University Medical Center

    Beersheba

Other trials in Israel

About this study

Official title: Feasibility Study: Enzymatic Debridement in Patients With Partial Thickness Burns (Children & Adults)- Protocol MW2008-09-03

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.

Read more

The objectives of this study are as follows:

  1. To evaluate the safety and efficacy (exploratory) of DGD in hospitalized patients with Partial Thickness (mid and deep dermal) thermal burns of 4-30% total body surface area (TBSA), but with total burn wounds of no more than 30% TBSA. Measures have already been taken in previous studies involving deeper wounds to control safety parameters (such as pain, fever and infection). Nevertheless, as part of the effort to expand the burn population in the future phase 3 study to the more superficial wound group, it is important to first explore these parameters in a small group involving this burn population.
  2. To explore DGD absorption as measured by Pharmacokinetic testing.
Read the detailed description

on-going recruitment, children and adults

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

    DGD is a mixture of lyophilized enzymes derived from purified Bromelain from pineapple stem.

    Two grams or 5 grams of Debrase powder are dissolved in 20 grams or 50 grams of Gel Vehicle to obtain DGD. DGD is applied to the burn wound at a dose of 2g Debrase/20g Gel per 100 cm2 of skin or 5g Debrase/50g Gel per 250 cm2 for a duration of four hours. In an average human adult, 100 cm2 represents approximately 1% of Total Body Surface Area (TBSA).

    Please note that for individuals of exceptional size (e.g. children), it is important to calculate the dosage based on the 100 cm2 measurement.

    The Debrase powder and the Gel Vehicle are to be mixed at the patient bedside for a maximum of 15 min prior to use.

    DGD should not be applied to more than 15% TBSA in one session. If the wound area to be treated is more than 15% TBSA, DGD should be applied in two or more separate sessions.

    DGD should not be applied more than twice to the same burn wound area.

Study groups in NCT00898521
Study groupRoleWhat they receive
DGDExperimentalNot described
Receives: Drug: DGD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is safety as measured by: 1. Systemic an local adverse events, 2. Changes in vital signs and laboratory tests, 3. Time to wound closure.

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2009 (estimated)
  2. Study start20 Dec 2009
  3. Primary completion2 Dec 2015
  4. Study completion2 Dec 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00898521
Sponsor's protocol ID
MW2008-09-03
Status last verified
Apr 2011
First submitted
11 May 2009
Last updated
9 Sep 2021
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 15555800

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DGD in people with Burn, run by MediWound Ltd at 2 sites in 2 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 9 inclusion and 22 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 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India, Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The primary endpoint is safety as measured by: 1. Systemic an local adverse events, 2. Changes in vital signs and laboratory tests, 3. Time to wound closure. (time frame: Throughout the study). 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 NCT00898521, which also lists 1 linked publication.

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 9 Sep 2021.

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