WO2021186188A1 - Debridement composition - Google Patents
Debridement composition Download PDFInfo
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- WO2021186188A1 WO2021186188A1 PCT/GB2021/050683 GB2021050683W WO2021186188A1 WO 2021186188 A1 WO2021186188 A1 WO 2021186188A1 GB 2021050683 W GB2021050683 W GB 2021050683W WO 2021186188 A1 WO2021186188 A1 WO 2021186188A1
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- wound
- wound dressing
- debridement tool
- present
- composition
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/48—Surfactants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/42—Use of materials characterised by their function or physical properties
- A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
Definitions
- the present disclosure relates to the field of wound care and relates, in particular to a composition, wound dressing or other debridement formulation or aide to promote and enhance the natural cleansing mechanism of autolytic debridement.
- the physiology of skin makes it a remarkably resilient organ.
- the outer layer (the stratum corneum) consists of scales formed from dead epithelial cells that have become flattened and compressed with skin oils (sebum).
- stratum corneum provides a flexible and effectively waterproof barrier. It is elastic and resilient, but, because it is simply compressed layers, it can be eroded by repetitive frictional forces, or by the action of chemicals or breached by trauma to create a wound. Once the outer protective layer is removed the nerve endings become exposed leading to pain. The loss of the barrier leads to fluid leakage (exudation) and the underlying tissue is vulnerable to microbial invasion.
- Clean and acute wounds normally heal spontaneously with the aid of simple supportive physical measures such as a protective dressing.
- Autolytic (spontaneous, biochemically-mediated) debridement of non-viable tissue is part of the process of natural acute wound healing.
- the treatment of contaminated-traumatic, necrotic and chronic wounds can be more challenging and autolytic debridement may be inadequate.
- removal of contaminated and non-viable tissues is required before normal healing can be re-established.
- a well-qualified medical professional may be able to perform mechanical and/or sharp debridement to remove this non-viable matter, but nurses and less well qualified carers may not be as competent in performing such tasks or lack confidence. Under these circumstances less invasive debridement techniques are required.
- non-viable tissue may include necrotic (dead) tissues, slough (accumulating granulation and epithelial cells that are not surviving in the chronic wound environment) and biofilm (microbial matter including viable microorganisms and associated self-produced mucilage or extracellular polymeric substance (EPS)).
- necrotic (dead) tissues slough (accumulating granulation and epithelial cells that are not surviving in the chronic wound environment)
- biofilm microbial matter including viable microorganisms and associated self-produced mucilage or extracellular polymeric substance (EPS)
- Biofilm is viable microbial tissue that can re-establish and multiply rapidly, returning to its original condition within a few days or even a few hours. Slough is a consequence of the inflammatory phase of wound healing and it comprises dead or redundant white blood cells, fibrin/ fibroblasts, cellular debris/ components of healing, and liquified devitalised tissue. Slough can provide a source of nutrients for bacterial cells and a suitable environment for their proliferation, subsequently enabling biofilm formation.
- Necrotic tissue is an additional source of cellular debris in the form of fibrous proteins (such as collagen) and proteoglycans (components of the extracellular matrix).
- compositions capable of enhancing autolytic debridement. Such compositions may control biofilm before infection can occur.
- a wound dressing it would be desirable to have a composition that allows for loosening, softening and disrupting the non-viable material which further enhances the ability of absorbent materials to mechanically remove such material from the wound bed which is believed to then thus facilitate healing.
- surface-active agents may seem an obvious choice to aid in the removal of undesirable matter, but they can also be potentially detrimental (cytotoxic - causing the death of cells involved in healing locally or systemically toxic) and due consideration needs to be given to compatibility with other treatments being used simultaneously.
- Anti-biofilm agents must also be given similar consideration as must the tonicity and pH of the wound environment. Therefore, formulating for enhanced autolytic debridement is complex and requires more than an adaptive or additive approach. Barrier function, normal tonicity and pH need to be restored if pain and delays to healing are to be minimised.
- Wound cleansing compositions are disclosed in for example US, 5,284,833.
- US, 5,284,833 does not address the challenge of biofilm or the transient nature of irrigation products.
- US2017347661 (Al) describes a composition comprising antimicrobial metal ions and a quaternary cationic surfactant.
- the composition disrupts the biofilm EPS thereby increasing the efficacy of the antiseptic action of the metal ion and reducing the risk of infection. There is no reference to the disruption or removal of non-biofilm tissue.
- the disclosed technology in one embodiment relates to a composition comprising a chelating agent, an amphoteric surfactant and an anionic surfactant.
- composition further comprises a nonionic surfactant.
- the composition may be impregnated or coated into or placed onto a device that is placed in direct contact with a wound.
- the device may include a wound dressing or a debridement tool.
- the wound dressing and debridement tool may both have an absorbent layer.
- the debridement tool may have an absorbent layer and it may be a natural or synthetic material and in the form of a liquid or solid foam or mousse, a fabric, a technical textile or brush.
- the composition may for instance be in form of a mousse or a foam that can be generated in-situ after being applied as a liquid.
- the mousse or foam could stay in place in the wound and act as a wound dressing formed in-situ.
- the composition could be pre-formed and removed during or after the debriding process; a traditional foam product; a fabric wipe that is woven to produce a looped fibre surface; a nonwoven or calendered fabric such as a pad, a wipe or a pan scrub; a brush like fabric or tool where the fibres are either cut to give a flock-like finish or for example are monofilament.
- the disclosed technology in one embodiment relates to a debridement tool disclosed herein.
- a debridement tool may typically be used for mechanical debridement.
- the debridement tool may form instance be a sponge or pad.
- a common material used to prepare a sponge or pad is a foam, typically a polyurethane foam, polypropylene foam, polyester foam or polyvinyl alcohol (PVA) foam.
- a polyester foam may be useful for a wipe.
- a wound dressing may typically debride by autolysis.
- the disclosed technology relates to a wound dressing comprising an absorbent layer impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant.
- the absorbent layer may be in direct contact with the wound, or absorbent layer may have a wound contact layer between the absorbent and a wound. In one embodiment the absorbent layer is in direct contact with the wound.
- the disclosed technology wound dressing comprising an absorbent layer impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, an anionic surfactant, and a nonionic surfactant.
- hydrocarbyl includes a group such as alkyl, aryl, aralkyl, alkaryl, cycloalkyl or alkenyl, which may be linear or branched, and/or saturated or unsaturated, or may be ester derivatives thereof.
- the hydrocarbyl may include which a linear or branched an alkyl or alkenyl group, typically an alkyl group.
- composition ingredients is presented on a wt % basis, as well as on an area density (weight per area) basis dependent on the form and application of the product.
- %w/w may be most appropriate for a fluid product such as a liquid, gel or mousse
- an area density may be more appropriate to a flat sheet dressing.
- the area density basis is calculated by multiplying the wt % by a factor of 1.5.
- the disclosed technology defines an anionic surfactant.
- the anionic surfactant may be present at 0.05 to 1.5 wt %, or 0.1 to 1 wt %, or 0.1 to 0.5 wt %.
- the amount of anionic surfactant may be 0.075 to 2.25 grrr 2 , or 0.15 to 1.5 gnr 2 , or 0.15 to 0.75 gnr 2 .
- the anionic surfactant may include all forms of lipophilic oligomeric hydrocarbon and/or polyethoxylate with a negatively charged hydrophilic head group such as carboxylate, sulphate, sulphonate, sulphonated ester, sulphated ester, sulphated amide, carboxylated amide or phosphate anionic head group.
- a negatively charged hydrophilic head group such as carboxylate, sulphate, sulphonate, sulphonated ester, sulphated ester, sulphated amide, carboxylated amide or phosphate anionic head group.
- a fatty acid or fatty acid salt include a glutamate, a sulphosuccinate, a sarcosine, a sarcosinate, an isethionate, and a taurate.
- the anionic surfactant may be a salt, or an hydrocarbyl, or hydrocarbyl ester derivatives thereof, wherein the hydrocarbyl group contains 6 to 24, or 8 to 24 or 10 to 20 carbon atoms, typically in the form of a salt.
- the anionic surfactant may include a sulphosuccinate, a sarcosine, a glutamate.
- sarcosine sodium lauroyl sarcosinate.
- a sulphosuccinate may include di-sodium lauryl sulphosuccinate.
- An example of a glutamate is sodium cocoyl glutamate.
- the anionic surfactant comprises a fatty acid or fatty acid salt.
- the fatty acid or fatty acid salt may be a C8-24 fatty acid or fatty acid salt ora mixture thereof.
- the salt may be comprised of the fatty acid and an alkali metal or alkaline earth metal, typically the alkali metal.
- the alkali metal may for instance include sodium or potassium, typically sodium.
- the fatty acid of the C8-20 may have 10 to 20, or 12 to 18 carbon atoms.
- the fatty acid or fatty acid salt may be saturated or unsaturated.
- unsaturated the unsaturation may be mono- or di- unsaturation i.e., the fatty acid is a mono- or di- unsaturated fatty acid.
- the unsaturated fatty acid may contain a cis- or trans- double bond.
- the fatty acid or fatty acid salt is a fatty acid having 12-18 carbon atoms, mono-unsaturated and is classified as a monosaturated fatty acid.
- fatty acids examples include stearic, ricinoleic, oleic, eladic, petrolselinic, palmitic, erucic, behenic, lauric, myristic, or linoleic (such as 9,11-linoleic or 9,12-linoleic) acid.
- the fatty acid may be chosen from oleic acid, elaidic acid or petrolselinic acid.
- the fatty acid may be chosen from oleic acid, or elaidic, typically oleic acid.
- the fatty acid may be a di-unsaturated fatty acid such as 9,12 linoleic acid, and the salt is sodium linoleate.
- amphoteric Surfactant in one embodiment is present at 0.01 to 1.5 wt %, or 0.02 to 0.8 wt %, or 0.05 to 0.5 wt %.
- the amount of amphoteric surfactant may be 0.015 to 2.25 gnr 2 , or 0.03 to 1.2 gnr 2 , or 0.075 to 0.75 gnr 2 .
- amphoteric surfactant is present at or 0.05 to 0.4 wt % (or 0.075 to 0.6 gnr 2 ).
- the amphoteric surfactant may include an hydrocarbyl-amphoacetate, alkenyl- amphoacetate, hydrocarbyl-amphodiacetate, alkenyl-amphodiacetate, hydrocarbylampho- propionate, hydrocarbylampho-dipropionate, or hydrocarbylamphohydroxypropyl sultaine, wherein the hydrocarbyl and alkenyl groups contain 6 to 24, or 8 to 24, or 10 to 20 carbon atoms.
- the amphoteric surfactant has a counter-ion of an alkali metal such as sodium or an ammonium.
- amphoteric surfactant examples include sodium cocoamphoacetate, or cocoamidopropyl betaine, lauryl betaine, and hydroxysultaine. In one embodiment the amphoteric surfactant may be sodium cocoamphoacetate.
- the disclosed technology herein comprises a chelating as defined herein.
- the chelating agent may be in the form of a salt comprising negatively charged and positively charged ions.
- Positively charged ion(s) may include an ammonium, or Group I of the periodic table alkali metal, for example sodium or potassium.
- the chelating agent may present at 0.01 to 1 wt %, or 0.1 to 0.75 wt %, or 0.1 to 0.5 wt %.
- the amount of chelating may be 0.015 to 1.5 gnr 2 , or0.15 to 1.125 gnr 2 , or 0.15 to 0.75 gnr 2 .
- the wound dressing disclosed herein may be impregnated or coated with the chelating agent, and the chelating agent may comprise a hydroxy-carboxylic acid ester or amide, acid, or salts thereof for agents including (for example a citrate or citric acid, tartrate or tartaric acid, tartramide, or tartrimide, a lactate or lactic acid, maleate or maleic acid, glycolate or glycolic acid, oxalate or oxalic acid , gluconate or gluconic acid, a phosphate such as an orthophosphate, a polyphosphate, a pyrophosphate, or a salt of an aminopolycarboxylic acid such as ethylenediaminetetra-acetic acid (EDTA), l,2-bis(o- aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (BAPTA), ethylene glycol-bis( -aminoethyl ether)-N,N,N',N
- the chelating agent may be a salt of EDTA.
- the chelating agent may in one specific embodiment be EDTA, and EDTA is a mixture of di-, tri- or tetra-basic salts of EDTA.
- the EDTA salt may for instance be di-sodium salt of EDTA, or calcium di-sodium salt of EDTA, or tetra-sodium salt of EDTA.
- the salt of EDTA may be a mixture of salts of EDTA. Without being bound by theory it is believed that EDTA when present may be in the form of di- or tri- or tetra- basic salt, and the specific form of the salt will depend on the pH of a wound site.
- EDTA may be added to the composition as tetra-sodium EDTA.
- the chelate comprises an oxalate.
- the chelate comprises a hydroxy-carboxylic acid ester, salt, or amide thereof.
- the salt may be a citrate salt for example mono- or di- or tri- potassium citrate., or mono- or di- or tri- sodium citrate.
- the chelating agent comprises a hydroxycarboxylic acid salt, and the salt may be mono- or di- or tri- sodium citrate, typically tri- sodium citrate.
- the chelate comprises a phosphate.
- the phosphate may be an ortho-phosphate, a pyrophosphate, a tripolyphosphate or a derivatised phosphate.
- the phosphate is typically in the form ora potassium or sodium salt. Examples of the phosphate include potassium phosphate dibasic, potassium pyrophosphate, tri-sodium ascorbate phosphate, and sodium tripolyphosphate. An example of a derivatised phosphate being sodium ascorbyl phosphate.
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is present at 0.01 to 1 wt % (or 0.015 to 1.5 gnr 2 ), the anionic surfactant is present at 0.05 to 1.5 wt % (or 0.075 to 2.25 gnr 2 )), and the amphoteric surfactant is present at 0.01 to 1.5 wt % (or 0.015 to 2.25 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is present at 0.1 to 0.75 wt % (or 0.15 to 1.125 gnr 2 ), the anionic surfactant is present at or 0.1 to 1 wt % (or 0.15 to 1.5 gnr 2 ), and the amphoteric surfactant is present at or 0.02 to 0.8 wt % (or 0.03 to 1.2 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is present at 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 ), the anionic surfactant is present at or 0.1 to 0.5 wt % (0.15 to 0.75 gnr 2 ), and the amphoteric surfactant is present at or 0.05 to 0.5 wt % (or 0.075 to 0.75 gnr 2 ).
- the composition may be impregnated composition may be impregnated or coated in the wound dressing or debridement tool disclosed herein above may comprise: the amphoteric surfactant may be chosen from an hydrocarbyl- amphoacetate, alkenyl-amphoacetate, hydrocarbyl-amphoacetate, alkenyl- amphoacetate, hydrocarbylampho-propionate, hydrocarbylampho-dipropionate, or hydrocarbylamphohydroxypropyl sultaine, wherein the hydrocarbyl groups contain 6 to 24, or 8 to 24 carbon atoms; the anionic surfactant may be chosen from a fatty acid or fatty acid salt, sodium hydrocarbyl sulphates, hydrocarbyl ammonium sulphates, hydrocarbyl sulphosuccinates, hydrocarbyl sarcosines, hydrocarbyl sarcosinates, an hydrocarbyl isethionate, and hydrocarbyl taurates; and the chelating
- the composition may be impregnated or coated in the wound dressing or debridement tool disclosed herein above may comprise: the amphoteric surfactant may be chosen from an hydrocarbyl-amphoacetate, alkenyl-amphoacetate, hydrocarbyl-amphodiacetate, alkenyl-amphodiacetate, hydrocarbylampho-propionate, hydrocarbylampho-dipropionate, or hydrocarbylamphohydroxypropyl sultaine, wherein the hydrocarbyl groups contain 6 to 24, or 8 to 24 carbon atoms; the anionic surfactant may be chosen from a fatty acid or fatty acid salt, a sulphosuccinate, a sarcosine, or a sarcosinate; and the chelating agent may be chosen from an oxalate, a phosphate, a citrate, or a salt of EDTA.
- the amphoteric surfactant may be chosen from an hydrocarbyl-amphoacetate, al
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is a salt of EDTA and is present at 0.01 to 1 wt % (or 0.015 to 1.5 gnr 2 ), the anionic surfactant is present at 0.05 to 1.5 wt % (0.075 to 2.25 gnr 2 ), and the amphoteric surfactant is present at 0.01 to 1.5 wt % (or 0.015 to 2.25 gnr 2 ).
- the chelating agent is a salt of EDTA and is present at 0.01 to 1 wt % (or 0.015 to 1.5 gnr 2 )
- the anionic surfactant is present at 0.05 to 1.5 wt % (0.075 to 2.25 gnr 2 )
- the amphoteric surfactant is present at 0.01 to 1.5 wt % (or 0.015 to 2.25 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is a salt of EDTA and is present at 0.1 to 0.75 wt % (or 0.15 to 1.125 gnr 2 ), the anionic surfactant is present at or 0.1 to 1 wt % (0.15 to 1.5 gnr 2 ), and the amphoteric surfactant is present at or 0.02 to 0.8 wt % (0.03 to 1.2 gnr 2 ).
- the chelating agent is a salt of EDTA and is present at 0.1 to 0.75 wt % (or 0.15 to 1.125 gnr 2 )
- the anionic surfactant is present at or 0.1 to 1 wt % (0.15 to 1.5 gnr 2 )
- the amphoteric surfactant is present at or 0.02 to 0.8 wt % (0.03 to 1.2 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is a salt of EDTA and is present at 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 ), the anionic surfactant is present at or 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 ), the amphoteric surfactant is present at or 0.05 to 0.5 wt % (or 0.075 to 0.75 gnr 2 ).
- the chelating agent is a salt of EDTA and is present at 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 )
- the anionic surfactant is present at or 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 )
- the amphoteric surfactant is present at or 0.05 to 0.5 wt % (or 0.075 to 0.75 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is a salt of EDTA and is present at 0.01 to 1 wt % 0.015 to 1.5 grrr 2 ), the anionic surfactant is a fatty acid or fatty acid salt and is present at 0.2 to 1 wt , the amphoteric surfactant is present at 0.01 to 1.5 wt % (or 0.015 to 2.25 gnr 2 ).
- the chelating agent is a salt of EDTA and is present at 0.01 to 1 wt % 0.015 to 1.5 grrr 2
- the anionic surfactant is a fatty acid or fatty acid salt and is present at 0.2 to 1 wt
- the amphoteric surfactant is present at 0.01 to 1.5 wt % (or 0.015 to 2.25 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is a salt of EDTA and is present at 0.1 to 0.75 wt % (or 0.15 to 1.125 gnr 2 ), the anionic surfactant is a fatty acid or fatty acid salt and is present at or 0.25 to 0.7 wt %, and the amphoteric surfactant is present at or 0.02 to 0.8 wt % (or 0.03 to 1.2 gnr 2 ).
- the chelating agent is a salt of EDTA and is present at 0.1 to 0.75 wt % (or 0.15 to 1.125 gnr 2 )
- the anionic surfactant is a fatty acid or fatty acid salt and is present at or 0.25 to 0.7 wt %
- the amphoteric surfactant is present at or 0.02 to 0.8 wt % (or 0.03 to 1.2 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may comprise of: the chelating agent is a salt of EDTA and is present at 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 ) the anionic surfactant is a fatty acid or fatty acid salt and is present at or 0.1 to 0.5 wt % (or 0.15 to 0.75 gnr 2 ), the amphoteric surfactant is present at or 0.05 to 0.5 wt % (or 0.075 to 0.75 gnr 2 ).
- the composition may be impregnated or coated in the wound dressing or debridement tool may further comprise a nonionic surfactant.
- the nonionic surfactant may provide addition stability for the composition may be impregnated or coated in the wound dressing absorbent layer or debridement tool.
- the nonionic surfactant may be present at 0.01 to 0.7 wt %, or 0.05 to 0.5 wt %, or 0.1 to 0.3 wt %.
- the amount of nonionic surfactant may be 0.015 to 1.05 gnr 2 , or 0.075 to 0.75 gnr 2 , or 0.15 to 0.45 gnr 2 .
- the composition may be impregnated or coated in the wound dressing or debridement tool may further comprise a nonionic surfactant and the composition disclosed herein may contain: the chelating agent is present at 0.01 to 1 wt % (or 0.015 to 1.5 gnr 2 ), the anionic surfactant is present at 0.05 to 1.5 wt % (or 0.075 to 2.25 gnr 2 ), the amphoteric surfactant is present at 0.01 to 1.5 wt % (or 0.015 to 2.25 gnr
- the nonionic surfactant may be present at 0.01 to 0.7 wt % (or 0.015 to 1.05 gnr 2 ).
- the nonionic surfactant may include esters of fatty acids, fatty acid amides, fatty acid ethoxylates, fatty acid amide ethoxylates, polyethoxylated compounds and polyalkyl ethers, polyhydroxyl compounds, hydrocarbyl glucosides and amine oxides.
- esters of fatty acids fatty acid amides, fatty acid ethoxylates, fatty acid amide ethoxylates, polyethoxylated compounds and polyalkyl ethers, polyhydroxyl compounds, hydrocarbyl glucosides and amine oxides.
- polyoxyethylene fatty acid esters polyoxyethylene sorbitan fatty acid ester
- polyoxyethylene glycol fatty acid esters polyoxyethylene glycol fatty acid esters
- sucrose fatty acid esters sucrose fatty acid esters
- polyoxyethylene hydrogen carbonate castor oils and polyoxyethylene alkyl ethers (polyoxyethylene hydrogenated castor oil) ether (polyoxyethylene al
- the nonionic surfactant may include polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, PEG-40 stearate, PEG-100 stearate, sucrose stearate, sucrose myristate, isopropyl myristate, sucrose oleate, sucrose palmitate, sucrose laurate, laureth-21 (laureth field 21), ceteth-15 (ceteth field 15), steareth-20 (steareth field 20), oleth-15 (oleth field 15), beheneth-20 and ceteareth-20 (beheneth field 20).
- the nonionic surfactant may be a polysorbate, typically polysorbate 20.
- the wound dressing disclosed herein may comprise at least one layer composed of a foam, fabric or technical textile.
- the textile may be a nonwoven or woven fibrous layer, or a gel-forming fibre, or gauze.
- Gauze may be made from a cellulose such as cotton or viscose.
- the wound dressing absorbent layer is a gel-forming fibre impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant.
- the wound dressing absorbent layer is a gel-forming fibre impregnated or coated with a composition comprising a chelating agent, an amphoteric surfactant, an anionic surfactant and a nonionic surfactant.
- the disclosed technology relates to the use of the wound dressing for the treatment of a wound, wherein the wound contains biofilm.
- the disclosed technology relates to the use of the wound dressing to remove slough, necrosis or other foreign matter from a wound.
- the disclosed technology relates to the use of the wound dressing to prevent or minimise slough accumulation in a wound, by contacting the wound dressing disclosed herein with a wound.
- the disclosed technology relates to a method or preventing or minimising slough accumulation in a wound, by contacting the wound dressing disclosed herein with a wound.
- the wound dressing does not provide a chemically-induced microbicidal effect.
- the disclosed technology relates to a composition
- a composition comprising a chelating agent, an amphoteric surfactant, and an anionic surfactant for use in the treatment of a wound, such as a chronic wound, acute wound, burn, a wound comprising a bacterial biofilm or a wound comprising slough.
- a wound such as a chronic wound, acute wound, burn, a wound comprising a bacterial biofilm or a wound comprising slough.
- the composition may be as described hereinabove for any other embodiment of the invention.
- wound may include an injury to living tissue and may be caused by a cut, blow, or other impact, abrasion, pressure, heat or chemical; typically, one in which the skin is cut or broken.
- a wound may often be described as chronic or acute. Acute wounds may occur as a result of surgery or trauma. Typically, when not too severe and where the victim is otherwise in good health, wounds progress through well-defined stages of healing within a predicted timeframe. Chronic wounds begin as acute wounds. An acute wound can become a chronic wound when it does not follow the normal healing pathway resulting in a lengthened recovery. It is believed that the transition from acute to chronic wound can be due to an inadequate immune response for example: the patient being immuno-compromised, the wound being insufficiently perfused or being highly contaminated.
- Chronic wounds may include for example: venous ulcers (such as those that occur in the legs due to venous insufficiency), which account for the majority of chronic wounds and mostly affect the elderly; diabetic ulcers (for example, foot or ankle ulcers); arterial ulcers (due to peripheral arterial disease); and pressure injuries due to immobility.
- venous ulcers such as those that occur in the legs due to venous insufficiency
- diabetic ulcers for example, foot or ankle ulcers
- arterial ulcers due to peripheral arterial disease
- pressure injuries due to immobility may include for example: venous ulcers (such as those that occur in the legs due to venous insufficiency), which account for the majority of chronic wounds and mostly affect the elderly; diabetic ulcers (for example, foot or ankle ulcers); arterial ulcers (due to peripheral arterial disease); and pressure injuries due to immobility.
- Wounds may also include a deep tissue injury.
- Deep tissue injury is a term proposed bythe National Pressure Ulcer Advisory Panel (NPUAP) to describe a unique form of pressure ulcers. These ulcers have been described by clinicians for many years with terms such as purple pressure ulcers, ulcers that are likely to deteriorate and bruises on bony prominences.
- NPUAP National Pressure Ulcer Advisory Panel
- the disclosed technology relates to the subject matter as defined above.
- thin is known to the skilled person and may be defined as a layer or mass of dead tissue separated from surrounding living tissue, or tissue that is adhered to a wound but capable of being removed as in a wound, sore, or inflammation.
- the wound dressing disclosed herein may have a thickness between 0.5 to 20, or 2 to 10, or 3 to 7 mm.
- the wound dressing may be buffered to have a pH of 4-10, or 5- 8, or 5.5-6.5.
- the wound dressing may be comprised of one or more layers selected from the group comprising an outer cover layer, an absorbent layer, a gel-forming fibre, an adhesive layer, a wound contact layer, a distribution layer, and combinations thereof.
- a wound dressing includes one or more absorbent layer(s).
- the absorbent layer may be a foam or a structure derived from a superabsorbent polymeric material. If foam is used, the foam may also act as a distribution layer.
- the wound dressing comprises an outer cover layer and one or more absorbent layer(s) in combination with a gel-forming fibre.
- the gel-forming fibre typically is in direct contact with the wound, and thus no additional wound contact layer is required.
- gel forming fibres By gel forming fibres is meant hygroscopic fibres which upon the uptake of wound exudate become moist slippery or gelatinous.
- the gel forming fibres can be of the type which retain their structural integrity on absorption of exudate or can be of the type which lose their fibrous form and become an amorphous or structureless gel.
- the gel forming fibres are typically sodium carboxymethylcellulose fibres, chemically modified cellulosic fibres, alkyl sulphonate modified cellulosic fibres such as those described in WO2012/061225, pectin fibres, alginate fibres, chitosan fibres, hyaluronic acid fibres, or other polysaccharide fibres or fibres derived from gums, as well as non-cellulose synthetic fibres such as poly(vinyl alcohol) and polyacrylate.
- the gel forming fibres may be chemically modified carboxymethylcellulose fibres, typically sodium carboxymethylcellulose fibres.
- the absorbent layer is the gel-forming fibres, and the dressing does not contain additional dressing layers.
- the gel forming fibres are typically chemically modified cellulosic fibres in the form of a fabric and in particular carboxymethylated cellulose fibres as described in PCT WO00/01425.
- Sodium carboxymethylcellulose fibres typically have a degree of substitution of at least 0.05 carboxymethyl groups per glucose unit.
- the gel forming fibres typically have an absorbency of at least 2 grams (or at least 8 grams, or at least 10 grams), 0.9% saline solution per gram of fibre (as measured by BS EN 13726-1 (2002) "Test methods for primary wound dressings", section 3.2 "Free swell absorptive capacity").
- the carboxymethylated cellulosic fabrics typically have a degree of substitution between 0.12 to 0.35 (as defined in WO00/01425) more typically a degree of substitution of between 0.20 and 0.30 such that the absorbency of a fabric produced from is increased when compared to the unmodified cellulose.
- Particular useful fabrics have an absorbency of between lOg/g of to 30g/g of isotonic aqueous solution as measured by the method described in BS EN 13726-1 (2002).
- the cellulosic fabric typically consists solely of cellulosic fibre but may contain a proportion of a textile fibre or gel forming fibre.
- This textile fibre may be for example a cellulose fibre of a known kind and may comprise continuous filament yarn and/or staple fibre.
- the absorbent layer can be in direct contact with the wound, or comprise a wound contact layer, positioned between the wound and the absorbent layer.
- the wound contact layer is capable of absorbing exudate from the wound and transmitting it to the absorbent layer.
- the wound contact layer in one embodiment comprises gel-forming fibres, or a silicone gel.
- the superabsorbent may be a polyacrylate or starch polymer.
- the absorbent layer may be a foam.
- the foam may have an open cell and/or closed cell structure.
- the foam may be derived from polyurethane, polyvinyl alcohol, a collagen, a chitosan.
- the foam may be a polyurethane foam.
- the wound dressing disclosed herein may be prepared by a process comprising applying to the absorbent layer a composition comprising a chelating agent, an amphoteric surfactant as disclosed herein.
- a composition comprising a chelating agent, an amphoteric surfactant as disclosed herein.
- Inclusion of the disclosed technology in a wound dressing or similar wound treatment device can be achieved by addition to the material from which the device is constructed or by addition to the finished device.
- the technology may be:
- a viscous liquid such as an alcohol (for example hexanol), a polyol (for example propan-1, 2-diol or glycerol), a hydrophilic hydrocarbon (for example a polyethylene oxide)) or by the order of addition of the invention itself (for example a liquid surfactant such as liquid fatty acid or fatty acid salt or a liquid fatty acid that will form the salt in situ).
- a viscous liquid such as an alcohol (for example hexanol), a polyol (for example propan-1, 2-diol or glycerol), a hydrophilic hydrocarbon (for example a polyethylene oxide)) or by the order of addition of the invention itself (for example a liquid surfactant such as liquid fatty acid or fatty acid salt or a liquid fatty acid that will form the salt in situ).
- the technology may be added via similar washing, coating, spraying or powder coating.
- the technology may be added by suspending the technology in a non solvent and passing this through the device such that the suspended technology is mechanically trapped (i.e. positively added by filtration of the technology); • or added as an ink or pigment by a printing process, for example a screen-printing process, where the addition can be closely controlled by use of the screen.
- the print could be a continuous, for example as achieved by flood-coating, or, more preferably as a discontinuous coating (regular or random patterned) as it has less impact on the devices porosity/breathability, flexibility and ability to contour to the complex topography of the wound bed and both the macroscopic (physiology) and microscopic (cellular) levels.
- a wound matrix is prepared to contain:
- the simulated wound matrix is crosslinked with 1.5% w/w calcium chloride for 18 hours onto a solid phase screening system (96-peg microtiter plate lid).
- the pegs are dipped into the simulated wound matrix and immediately transferred to a calcium chloride bath to achieve cross-linking.
- Solutions of test materials are prepared at 1% w/w in a 96 well microtiter plate. Following crosslinking, the pegs are inserted into the wells and incubated at 37 °C for 1 hour. Efficacy is characterised by the change in colour of the test solutions resulting from disruption of the stained material and is quantified by reading the absorbance of each solution at 595 nm.
- HLB value is predictive of the efficacy of detergency of certain surfactants and would typically be used to guide selection, the higher the HLB value the greater the predicted detergency.
- the ability of the surfactants (with published HLB values) at l%w/w to disrupt the simulated test wound matrix does not correlate as might be expected.
- Sodium lauryl sulphate (SLS) is regularly used as a bench mark for high detergency but is also regarded as being too harsh for routine use in personal care products.
- Di-sodium lauryl sulfosuccinate is regarded as a milder alternative to SLS.
- Sodium oleate the basis for traditional bar-soap, is also generally accepted as being an inferior cleaning agent to SLS, yet both sodium oleate and di-sodium lauryl sulfosuccinate have efficacies an order of magnitude greater than SLS in disrupting the simulated test wound matrix.
- sodium oleate and di-sodium lauryl sulfosuccinate have efficacies an order of magnitude greater than benzalkonium chloride, cocoamidopropyl betaine and PoloxamerTM 188 all of which are commonly used in liquid wound cleansing products.
- the simulated test wound matrix is cross-linked and fixed onto the test surface by treatment with calcium chloride. It may therefore seem obvious that this fixation could be reversed by application of a compound that can compete for calcium and remove it, for example by precipitation as a poorly soluble salt. It would seem reasonable to assume that lack of solubility of a calcium chelating agent could be used as a predictor of the ability of that agent to remove calcium from the matrix and therefore be of higher matrix disruptive potential. Calcium citrate (at pH 7.5) is significantly more soluble than calcium oxalate at the same pH, yet citrate shows greater efficacy in the simulated test wound matrix than an equivalent w/w of oxalate.
- Example 2 The combined effect of surfactants and chelants is investigated when presented as a coating on a wound dressing that gels in the presence of water [AQUACEL ® Extra, ConvaTec PLC] Dressings without surfactant or chelator are used as controls.
- the test model from Example 1 is adapted to accommodate solid test materials.
- the simulated wound matrix is cast onto cellulose acetate sheets using a thin film applicator (1.5 mm wet thickness) and submerged face-down into 1.5% w/w calcium chloride for 24 hours.
- Test dressings are cut to 2 cm 2 , hydrated with 1 ml Test Solution A (BS EN 13726-1:2002), placed onto the substrate and incubated 37 °C for 18 hours. Efficacy is characterised by the change in colour of the dressings resulting from absorption of liquified test matrix containing crystal violet dye.
- the solubilised fraction is quantified by extraction of the crystal violet stain from the dressings by adding 2 ml of 33% v/v acetic acid and extracting for 30 minutes on a roller mixer. The absorbance of each resultant solution is read at 595 nm. Results on a % w/w basis:
- Test substances are described as a weight percentage of the dry dressing.
- the dressings in the example absorb high volumes of aqueous liquids (approximately 23 g/g in this instance) and the function of the test substances is facilitated by moisture, due consideration must be given to dilution effects. 1.0% w/w in this example approximates to a 0.043% solution if tested as in Example 1. Therefore, much reduced effects might be anticipated. However, significant improvement is achieved over both the control and the cationic surfactant/chelator comparators. No improvement in performance is observed for the individual or combined increase in concentration of the test substances.
- each chemical or composition referred to herein should be interpreted as being a commercial grade material which may contain the isomers, by products, derivatives, and other such materials which are normally understood to be present in the commercial grade.
Abstract
Description
Claims
Priority Applications (8)
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CA3175431A CA3175431A1 (en) | 2020-03-20 | 2021-03-19 | Debridement composition |
AU2021238941A AU2021238941A1 (en) | 2020-03-20 | 2021-03-19 | Debridement composition |
EP21714257.9A EP4121129A1 (en) | 2020-03-20 | 2021-03-19 | Debridement composition |
BR112022017532A BR112022017532A2 (en) | 2020-03-20 | 2021-03-19 | DEBRIDEMENT COMPOSITION |
JP2022556073A JP2023518943A (en) | 2020-03-20 | 2021-03-19 | Debridement composition |
US17/206,822 US20210290815A1 (en) | 2020-03-20 | 2021-03-19 | Debridement Composition |
CN202180022411.9A CN115297902A (en) | 2020-03-20 | 2021-03-19 | Debridement composition |
CONC2022/0012306A CO2022012306A2 (en) | 2020-03-20 | 2022-08-29 | Debridement Composition |
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GBGB2004055.6A GB202004055D0 (en) | 2020-03-20 | 2020-03-20 | Debridement Composition |
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US17/206,822 Continuation US20210290815A1 (en) | 2020-03-20 | 2021-03-19 | Debridement Composition |
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Cited By (1)
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GB202305225D0 (en) | 2023-04-06 | 2023-05-24 | Convatec Ltd | Wound cleansing composition |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5284833A (en) | 1991-06-24 | 1994-02-08 | Carrington Laboratories, Inc. | Wound cleanser |
WO2000001425A1 (en) | 1998-07-01 | 2000-01-13 | Acordis Speciality Fibres Limited | Wound dressings and materials suitable for use therein |
WO2012061225A2 (en) | 2010-11-01 | 2012-05-10 | Becton, Dickinson And Company | Gardnerella vaginalis assay |
US20120122755A1 (en) * | 2010-11-15 | 2012-05-17 | Sasa Andjelic | Polyglyceryl compounds and compositions |
WO2012136968A1 (en) | 2011-04-06 | 2012-10-11 | Convatec Technologies Inc | Composition comprising antimicrobial metal ions and a quaternary cationic surfactant |
CN110559312A (en) * | 2019-09-16 | 2019-12-13 | 振德医疗用品股份有限公司 | Composition for wound treatment and application method thereof |
-
2020
- 2020-03-20 GB GBGB2004055.6A patent/GB202004055D0/en not_active Ceased
-
2021
- 2021-03-19 WO PCT/GB2021/050683 patent/WO2021186188A1/en active Application Filing
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5284833A (en) | 1991-06-24 | 1994-02-08 | Carrington Laboratories, Inc. | Wound cleanser |
WO2000001425A1 (en) | 1998-07-01 | 2000-01-13 | Acordis Speciality Fibres Limited | Wound dressings and materials suitable for use therein |
WO2012061225A2 (en) | 2010-11-01 | 2012-05-10 | Becton, Dickinson And Company | Gardnerella vaginalis assay |
US20120122755A1 (en) * | 2010-11-15 | 2012-05-17 | Sasa Andjelic | Polyglyceryl compounds and compositions |
WO2012136968A1 (en) | 2011-04-06 | 2012-10-11 | Convatec Technologies Inc | Composition comprising antimicrobial metal ions and a quaternary cationic surfactant |
US20170347661A1 (en) | 2011-04-06 | 2017-12-07 | Convatec Technologies Inc. | Composition comprising antimicrobial metal ions and a quaternary cationic surfactant |
CN110559312A (en) * | 2019-09-16 | 2019-12-13 | 振德医疗用品股份有限公司 | Composition for wound treatment and application method thereof |
Non-Patent Citations (1)
Title |
---|
GOSS SL ET AL., JOURNAL OF PHARMACY AND PHARMACOLOGY, vol. 59, no. 11, pages 1485 - 1492 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB202305225D0 (en) | 2023-04-06 | 2023-05-24 | Convatec Ltd | Wound cleansing composition |
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