KytoCel. Key Messages and Update Jan 2017

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1 KytoCel Key Messages and Update Jan 2017

2 Gelling Fibre Dressings KytoCel is a highly absorbent dressing composed of natural, biodegradable acetylated chitosan fibres Exufiber Patented Hydrolock technology gelling fibre dressing composed of sterile nonwoven dressing made from highly absorbent polyvinyl alcohol fibres Durafibre - has a unique non woven fibre blend made up of cellulose strengthening fibres and gelling cellulose ethyl-sulphonate fibres Aquafiber Contains a reinforcing layer hidden between two layers of absorbent fibres Aquacel The original hydrofiber dressing Hydrofiber is defined as a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose Hydrofiber is a patented term and so other dressings which are similar cannot call themselves hydrofibers Page 2 They all claim to be unique!

3 What Do They Do? Exudate management Reduction in wound bioburden Autolytic debridement Conformability to the wound bed reducing dead space Maintain moist wound environment Atraumatic removal Page 3

4 Product Characteristics Antimicrobial format available Conformable to wound bed Hydrofiber composition KytoCel Durafiber Aquafiber Aquacel Exufiber Haemostat Intact when saturated One piece removal Able to be used on infected wounds Page 4

5 How is KytoCel Different? It contains Chitosan! Chitin, extracted primarily from shellfish sources, is a unique biopolymer Chitosan is a product of deacetylation of chitin with concentrated alkaline solution Chitin is a common constituent of the exoskeleton in animals, particularly in crustaceans, molluscs and insects. The structure of chitosan (deacetylated chitin) is very similar to cellulose Much attention has been paid to chitosan based biomedical materials, because of its unique properties such as biodegradability, non-toxicity, anti-bacterial effect and biocompatibility. Chitosan is a benefit to wound healing because it stimulates haemostasis, accelerates tissue regeneration and has an anti-inflammatory effect Page 5

6 Chitosan Properties Chitosan provides a non-protein matrix for tissue growth Activates macrophages for tumoricidal activity Stimulates cell proliferation and histoarchitectural tissue organisation. It is a haemostat which helps natural blood clotting Can block nerve endings reducing pain Chitosan will gradually depolymerize to release N-acetyl-β-D-glucosamine, which initiates fibroblast proliferation, helps in ordered collagen deposition and stimulates increased level of natural hyaluronic acid synthesis at the wound site. It helps in faster wound healing and scar prevention (Paul and Sharma, 2004) Page 6

7 Schematic Representation of Benefits Of Chitosan in Wound Healing Paul and Sharma 2004 Page 7

8 Definition Of Antimicrobial Antimicrobial: A substance that acts directly on a microbe in a way that will either kill the organism or significantly hinder development of new colonies The term incorporates disinfectants, antiseptics and antibiotics Antimicrobial therapy may be required when other methods of eradication of wound infection are insufficient to manage localised wound infection, or when the infection is systemic/spreading International Wound Infection Institute 2016 Page 8

9 How Do Antimicrobials Work? Bactericidal: Agents that kill bacteria through single or multiple cellular processes Bacteriostatic: Refers to bacterial multiplication/growth that has been prevented or inhibited, but may resume if the inhibitory agent is removed. IWII 2016 Pseudomonas Barbie! Page 9

10 Chitosan Mode of Action on Microbes Two trains of thought: Chitosan can penetrate into the cells and attach to the cytoplasm disturbing the cell metabolism and causing the death of bacteria. It attracts itself to the cell wall of the bacteria therefore killing the bacteria inside. The greater the negative charge, the greater it s attraction. Chitosan s bacteriostatic properties is that, the positive charge of a chitosan molecule neutralizes the negative charge of a bacterium s cell membrane causing damage to the bacterium cell wall small molecules of chitosan penetrate through the damaged cell membrane into the cell nucleus. In the cell nucleus, chitosan binds to DNA molecules and inhibits the formation of bacterial DNA, giving antimicrobial capability. (Chung et al 2004) Page 10

11 Use Of KytoCel With Other Products Should we be promoting good wound bed preparation in order to ensure the greater effectiveness of KytoCel? Suggesting use of products such as PHMB wound cleansing fluid or the monofilament debridement pads Page 11

12 Key Difference Between KytoCel & Competitor Gelling Fibre Dressings Chitosan also has an accelerating effect on wound healing (Jayakumar et al, 2011) by activating immune cells through its cytokine production, giant cell migration, and stimulating type IV collagen synthesis (Mezzana, 2008) These actions support KytoCel during all stages of tissue repair (Dai et al, 2011) Other Gelling Fibre dressings do not accelerate wound healing Page 12

13 Where Does KytoCel Sit In The Market? It is a Gelling Fibre dressing and should be positioned alongside other Gelling Fibre dressings It is not to be placed alongside Silver dressings It was positioned for DT in the Protease Modulating Matrix category because it sequestrates exudate with proteases into the dressing but this is not where it is to be positioned Was placed in this category as it was positioned alongside Aquacel Page 13

14 Update On Absorbency KytoCel is now an extra 1/3 more absorbent than it was change in sterilisation process Page 14

15 Conclusion KytoCel is a Gelling Fibre dressing with additional benefits It is now one third more absorbent than before What is said in the marketing differs to what is in the IFUs as the marketing information relates to the benefits of Chitosan as a whole so we have the belief that KytoCel may have these benefits too It is made of Chitosan which has many other properties such as anti-inflammatory, cell proliferation etc. and we believe that KytoCel has these effects but we do not have evidence yet KytoCel can be referred to as an antimicrobial based on evidence we have and the definitions of the International Wound Infection Institute (2016) however, it is not to be positioned against other antimicrobials Page 15