- Background
- Debrase® Gel Dressing
- DGD burn treatment benefits
- Clinical Status
- Regulatory
Background:
A thermal burn is the tissue injury caused by exposure to high temperature and is characterized by death of living cells and denaturation of all protein structures. The severity of the burn injury is mainly determined by its depth and the % of Total Body Surface Area (TBSA) it occupies.
Second and third degree (partial and full thickness) burns result in necrotic burned tissue named Eschar. The necrotic eschar is a source of potential infection and greatly interferes with the wound healing process. The removal of the eschar, known as “debridement”, is a crucial step in preparing the wound bed for healing spontaneously or grafting. Currently, debridement involves long conservative topical treatment or surgical procedures which are often traumatic and involve blood lose, sacrifice of healthy tissue and the common risks associated with surgery. Surgery, even of a partial thickness burn may transform it into a full thickness one. The presence of the opaque eschar at the burn wound site does not allow accurate diagnosis of the wound's depth and consequently the choice of optimal treatment. This inconsistency often forces the physicians to delay initiation of definitive treatment. Severe burns generally require debridement by surgery, in which the dead tissue is "shaved" away, layer by layer (tangential excision) until the healthy tissue underneath is exposed. Once the wound bed is clean, physicians are able to diagnose the depth of the wound and determine the proper treatment strategy to achieve wound closure. Debridement would also remove the bacteria load existing on and inside the dead tissue, decreasing the risk for local and systemic infection. Initiation of the healing phase depends on a properly prepared wound bed devoid of any eschar.
In 2nd degree burns, if a residual clean exposed dermis survives, it may epithelialize and heal spontaneously. Full thickness 3rd degree burns, devoid of any healing sources (viable dermis and epithelium) will heal only if a living skin graft is "imported". The graft is harvested from healthy donor sites. These donor sites are additional wounds which must be treated separately and may involve further complications and scarring.
It is commonly accepted that thorough wound debridement should be performed as soon as possible post injury in order to prevent further deterioration and to preserve any viable tissue; this will facilitate spontaneous healing and minimize the need for grafting.
With this in mind, an ideal debriding agent should be:
– Effective: Removes the entire necrotic tissue from the burn wound
– Selective: Removes only the necrotic tissue (eschar) without harming viable tissue
– Fast: Removes the eschar as quickly as possible, preventing eschar related complications thus facilitating healing
– Safe: Does not involve trauma to the patient, blood loss, general anesthesia or other risks related to surgery
– Easy to use: No need for operating room facilities or personnel
Debrase® Gel Dressing (DGD) dissolves the eschar within four hours of application, providing an effective, selective, fast and safe alternative to current debriding means, such as surgery and non-surgical methods.
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Debrase® Gel Dressing (DGD)
Debrase® Gel Dressing (DGD), a novel Bromelain based enzymatic debriding agent, was developed by MediWound Ltd. to be used for the dissolution of eschar in deep partial thickness and full thickness burns. DGD dissolves the burn eschar within four hours of application, providing an effective, selective, fast and safe alternative to current debriding means, such as surgery and non-surgical methods.
DGD is a mixture of proteolytic enzymes extracted from the pineapple plant stem. The patented extraction and purification processes results in a pharmaceutical composition having high specificity and selectivity in the digestion of necrotic human cutaneous tissue.
DGD includes two components:
1. Debrase®: Lyophilized sterile mixture of proteolytic enzymes.
2. Gel: Sterile medical hydrating gel
2g or 5g of Debrase® powder are dissolved into either 20g or 50g of Gel, and used to treat 100cm² or 250cm² burn area respectively. In an average human adult, 100cm² represent 1% TBSA.
The mixture of both components is applied on the wound surface dissolving the eschar. In most cases >90% of the treated area is dissolved in a single 4 hour application. The dissolved eschar in the form of a gelatinous mass is simply wiped away, with no surgical or other special procedures, exposing the clean wound bed that is easily diagnosable and treated accordingly. If necessary, a second application may be performed.
The debrided wound bed preserves the viable dermal and epidermal components that may heal (epithelialize) spontaneously leaving only the full thickness areas to be grafted, resulting in overall less area grafted and skin harvested from healthy donor sites. Thus, DGD not only provides a good debridement treatment regimen, it also serves as an efficient diagnostic tool for early and accurate assessment of the injury extent, allowing educated planning for the future treatment strategy.
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DGD Burn Treatment Benefits:
Selective and effective:
In most cases, following a 4 hour application of DGD, >90% of the treated area is debrided. DGD will debride only the dead burn eschar without harming the vital dermis and epithelium that are essential for spontaneous healing of the burn wound. Therefore, treatment with DGD results in overall less area grafter and skin harvested from healthy donor sites.
Deep hand burn before blister removal
Following DGD debridement.
The skin protected by the watch, though exposed to DGD, was not harmed.
The changing depths of the debrided burn can easily be diagnosed based on their bleeding pattern.
Fast and non-traumatic debridement at patient bed:
As a first line therapy, DGD can be applied within hours of admission regardless of burn degree diagnosis. A complete debridement of the burn wound can be achieved within the first 24 hours post admission. This procedure does not require special operating room facilities or personnel. Treatment with DGD is simple to perform and does not involve the risks associated with surgery (such as trauma, blood loss, and effects of general anesthesia).
Enables accurate diagnosis:
The presence of the opaque eschar at the burn wound site does not permit accurate diagnosis of the wound's depth. DGD, by its selective and tissue sparing activity, exposes the various depths of the clean burn wound allowing early and accurate diagnosis of the various wound depths, followed by educated planning for the future treatment strategy.
Debridement of special areas:
Burns of the face, hands and feet involve special risks and demands. Selective, early non-surgical debridement of hand burns with DGD provides a clean wound bed early in the treatment process. DGD facilitates preservation of all the viable tissues and structures in the delicate and anatomically crowded hand. These structures are at risk in non selective, traumatic surgery or in the slow non-surgical procedures. Early adequate care of the clean bed will offer an optimal wound healing process and good long term esthetic and functional results.
 
A deep dermal hand burn Excellent complete debridement with DGD revealed the viable dermis
DGD based Minimal Invasive Modality
The DGD early effective, selective, fast and safe debridement followed by accurate diagnosis that allows wound-care tailored to the various burned areas in the basis for a unique Minimal Invasive Modality in burn care (MIM). After debridement, the exposed dermis is dressed and treated toward spontaneous epithelialization. Grafting is reserved only for the large full thickness defects and areas that did not heal within 2-3 weeks. MIM results in salvage of viable dermis otherwise sacrificed by surgical debridement or necrotized following long inflammation and infection of the slow non-surgical debridement. Additional benefit of debridement-related-tissue-sparing effect is exploitation of the healing potential of the salvaged dermis by its epithelialization. The end result is not only earlier and less traumatic debridement but also less excisional surgery under general anesthesia, less grafting with improved cosmesis and function and decreased donor site trauma and sequelae.
To conclude, MIM results in less sacrificed tissue during debridement, less surgery and decreased grafting with its donor site cost.
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Clinical Status
Initial Clinical Experience
The initial clinical experience is based on a retrospective, non-comparative, clinical trial of 154 patients with 401 wounds, adults and children, with deep second and third degree burns.
DGD was applied for 4 hours.
With DGD, debridement was achieved in 86.5 ± 22% of the intended area.
Only 42.7% of the wounds were grafted. Mostly 3rd degree burns.
Of those, only 20.5% were excised prior to grafting.
Mean time to wound closure was 22.9 days.
On a subset group of Children (n=74 wounds) treated with DGD, only 34% of the original wound area required grafting.
The mean wound closure time, for this subset group, was 18 days.
In an analysis of 81 hand wounds treated with DGD, only 37.5% hand burns were required grafting. Of those, only 6.7% underwent excision prior to grafting.
Meantime for hand wound closure was 21.1 days
The incidence of adverse events was similar to that of a burn disease patient.
Present Clinical Experience
MediWound is currently carrying out controlled Phase II and Phase III clinical trials in a number of burn centers in the US and the EC.
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Regulatory
Regulatory:
The FDA and the European CPMP granted MediWound Orphan Drug Status for Debrase®. This status grants the company exclusivity for 7 and 10 years, respectively, for debridement of deep partial or full thickness burns in hospitalized patients.
Patents and Trade Marks:
There are 5 patents covering MediWound's Debrase® Gel Dressing.
Debrase® is a registered trade mark of MediWound Ltd.
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