Method for Pre-Debriding Treatment of Non-Viable Skin Tissue and Compositions and System Thereof
AssigneesDermal Therapy (Barbados) Inc., Biomedical Concepts, Inc.
InventorsDonald H. LEAMAN, Alan Lorne PERLMUTTER
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Abstract
A pre-debriding composition comprises a chaotropic agent, preferably urea, and, preferably, exfoliating and analgesic agents. The pre-debriding composition reduces the collagen denaturation temperature, Tm, at the site of a wound. Use of the composition along with a supply of heat increases the effectiveness of a subsequent enzymatic debriding treatment. A dressing and heating system is also provided for use with the pre-debriding composition. An “instant activated” debriding composition and package is provided comprising a gel composition and a powdered debriding zymogen composition, wherein mixing of the two compositions results in an activated enzymatic debriding composition. 22290368.1
Claims32
A pre-debriding composition comprising:
- a first chaotropic component, wherein the first chaotropic component is:
- urea;
- N-alkyl-substituted urea or N,N-dialkyl-substituted urea having a C6 to C9 alkyl group;
- amides of formula (R2)2N—CO—R1—R3, wherein R1 represents a chemical bond or a C1 to C14 alkyl group, and R2 and R3 are independently hydrogen or CH3;
- dimethyl sulfoxide (DMSO);
- or a combination thereof;
- at least one of:
- an analgesic component, an exfoliating component, an unsaturated fatty acid, and a collagen re-naturing inhibitor;
- and,
- one or more of pharmaceutically acceptable thickening agents, emulsifiers, preservatives, carriers, diluents, adjuvants and excipients.
The pre-debriding composition of claim 2, wherein the first chaotropic component is present in a concentration of about 15 to 40 wt %.
A method of treating a wound site prior to debridement, the method comprising:
- a) applying to the wound site, at least one first chaotropic agent and at least one analgesic agent, for reducing the collagen denaturation temperature at the wound site, wherein the at least one first chaotropic agent is:
- urea;
- N-alkyl- substituted urea or N,N-dialkyl-substituted urea having a C6 to C9 alkyl group;
- amides of formula (R2)2N—CO—R1—R3, wherein R1 represents a chemical bond or a C1 to C14 alkyl group, and R2 and R3 are independently hydrogen or CH3;
- dimethyl sulfoxide (DMSO);
- or combinations thereof;
- and,
- b) applying heat to the wound site following application of the pre-debriding composition, said heat being applied for a period of time to cause denaturation of collagen at the wound site.
A system for heating a wound site following application of a pre-debriding composition to cause denaturation of collagen at the wound site, the system comprising:
- i) a first dressing layer for placement over the wound site, the first dressing layer comprising a non-absorbent material;
- ii) a temperature measuring or sensing means for positioning over the first dressing layer;
- iii) a second dressing layer, for placement over the temperature measuring or sensing means and over the first dressing layer, the second dressing layer comprising an absorbent material having a non-adherent layer, the second dressing layer including a fenestration corresponding to the wound site being treated;
- and,
- iv) a heating means for heating the wound site.
A composition for enzymatic debriding, wherein the composition is provided in two components consisting of a gel composition and a powder composition, wherein the powder composition comprises one or more proteolytic enzymes in their zymogen form and wherein the gel composition is adapted to activate one or more zymogens when the two components are mixed.
Dependencies are inferred from the claim text.