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  1. 1. Prontosan® solution/gel ... lavasepsis of chronic & acute wounds and burns FIRST WOUND HYGIENE- THEN WOUND TREATMENT  optimal wound conditioning  fast and effective removal of wound coatings and biofilm  accelerated wound healing  absorption of wound odours  can be used up to 8 weeks after opening
  2. 2. “Wound bed preparation: science applied to practice” V. Falanga EWMA Position Document, London: MEP Ltd. 2004. TIME Framework There are four components to wound bed preparation, which address the different pathophysiological abnormalities underly- ing chronic wounds: T - Tissue management I - Inflammation and infection control M - Moisture balance E - Epithelial/edge/ advancement What is the significance of the TIME framework? • Its practical significance involves opti- mum wound bed preparation by redu- cing inflammation, exudates, bacterial burden and, importantly, correcting the abnormalities contributing to impaired healing. This, in turn, should facilitate the normal endogenous process of wo- und healing.* • The TIME framework can be used to eva- luate the role of therapeutic interven- tions. A single intervention can impact more than one element of TIME, for example, debridement will not only re- move wound coatings but will also redu- ce the bacterial load. Inflammation and infection control • There is no question that clinical wound infection resulting in failure to heal must be treated promptly and effectively. • Evidence shows that bacteria contained in the biofilm become easily resistant to antimicrobials. • Intensive investigation is needed to de- termine the role of biofilms in delayed wound healing. (*(“providing the underlying intrinsic and extrinsic factors affecting wound healing have also been ad- dressed”) ) “Management of wound infections” CJ Moffatt, P Bowden, RA Cooper EWMA Position Document, London: MEP Ltd. 2006. • A wound does not have to be sterile to progress towards healing. • The use of topical antiseptics simply to lower microbial load in the healing wo- und can never be justified. • Adverse microbial involvement in de- layed healing must be suspected when other causes have been eliminated. • Although antiseptics play a major role in the reduction of infection during surgi- cal procedures and preoperative prophy- laxis (preoperative skin disinfection), in the case of closed surgical wounds, their use in the prevention and treatment of infections is unjustified and, so far, no investigations have proven their effecti- veness in this respect. RECOMMENDATIONS OF THE EUROPEAN WOUND MANAGEMENT ASSOCIATION (EWMA)
  3. 3. LAVASEPSIS E.g. betaine/PHMB solution, gel (Exemplary Products: Prontosan® solution, Pronto- san® gel). Mode of action: physical removal of wo- und coatings and biofilm using a detergent solution. APPLICATION: • For every type of surface wound. • Fast and effective removal of wound co- atings and biofilm (WOUND HYGIENE). • Infection prophylaxis (CHRONIC USE). • Rationalisation and restricted use of an- tibiotics and antiseptics. • Reduction of drug resistance develop- ment. • Obtaining an optimal therapeutic effect of the procedures, dressings and medici- nes used (including antiseptics and anti- biotics). • Acceleration of wound healing NOTES: • It cannot replace antisepsis ANTISEPSIS E.g. octenidine/phenoxyethanol, PVP-i- odine silver dressings (Exemplary Products: Braunol®, Braunovidon®). Mode of action: kill or inactivate microor- ganisms in the wound. APPLICATION: • Treatment of infected wound (SHORT- TERM APPLICATION). • Perioperative infection prophylaxis. • Disinfection of traumatic wounds (wo- und rinsing). NOTES: • Impediment of wound healing. • Do not use in the prevention of chronic and closed surgical wound infections • Do not use in wound hygiene: wound cleansing and biofilm removal IRRIGATION E.g. physiological saline solution, Ringer solution (Exemplary Products: Ecolav®). Mode of action: physical removal of wound coatings, moistening. APPLICATION: • Irrigation of all types of wounds (NO TIME CONSTRAINTS). • Perioperative wound irrigation. • Irrigation of traumatic wounds. • Flushing out antiseptics from the wound after disinfection. • Dressing moistening. NOTES: • Removal of wound biofilm or thorough cleansing of chronic wound is not possi- ble in practice due to absence of a deter- gent action. LAVASEPSIS, ANTISEPSIS, IRRIGATION Wound application according to TIME (overview) LAVASEPSIS T I M E ANTISEPSIS T I M E IRRIGATION T I M E
  4. 4. Wound Lavasepsis … the easiest way to effective topical wound treatment application of Prontosan® solution in routine wound management
  5. 5. Optimal wound bed preparation is essen- tial for ensuring effective application of a therapeutic strategy corresponding to the wound healing stage. Only then can wo- und-treatment measures (e.g., dressing, systemic antibiotic, antiseptic, bioactive product) or methods (e.g., debridement, skin transplantation) fully disclose their therapeutic potential. The biofilm problem If a wound is colonised, i.e., there are a number of germs on the wound surface, the metabolic products of these bacteria produce the so called, biofilm. This biofilm protects the bacteria from extrinsic envi- ronmental factors, and, consequently, from the effect of antibiotics and antiseptics. The biofilm facilitates undisturbed proli- feration of the bacteria it protects and at the same time acts as a docking station for other bacteria. As a result, there is a signi- ficant drop in the effectiveness of topical and systemic therapeutic measures. Wound lavasepsis Components of a lavaseptic (Prontosan®) reduce the surface tension of the aqueous solution permitting penetration and ef- fective removal of the biofilm, even in the case of fissured wounds. As a consequence the wound is cleansed thoroughly. Lavasepsis Traditional wound irrigation
  6. 6. Prontosan® state-of-the-art in lavasepsis REPORTS FROM SELECTED COMPARA- TIVE STUDIES Wound cleansing through removal of fi- brin coatings and exudate The study investigated the cleansing pro- perties of solutions used in chronic wound treatment: Prontosan® solution, physio- logical saline, Ringer solution, Lavanid® 1 and octenidine/phenoxyethanol solution. A model simulating the practical condi- tions occurring on a contaminated wound was used. Prontosan® solution demonstra- ted definitely the best cleansing properties. Prontosan® easily dissolved test deposits and released the proteins contained within. Lavanid® 1 solution dissolved coatings with a ca 10% lower effectiveness and the dissolution process was considerably slower. The next product with the highest effectiveness was physiological saline, fol- lowed by Ringer solution. The application of octenidine/phenoxyethanol solution caused immediate denaturation of the de- posit proteins leading to its decolouration and denaturation. For this reason, the pro- duct is not suitable for the separation and removal of organic debris from the wound surface. Kurt Kaehn, Zeitschrift fur Wundeheilung No. 1, 2007, p 12-17 and unpublished data Biofilm removal Comparative study on the efficacy of Pron- tosan® solution,physiological saline and Ringer solution in the elimination of bio- film in a model system using biofilm pro- duced by Pseudomonas aeruginosa. Phy- siological saline and Ringer solution were completely ineffective in biofilm removal. In contrast, Prontosan® eliminated the bio- film with a ca 87% efficacy. H-M Seipp et al., Zeitschrift für Wundheilung No. 4, 2005, p. 160-164. Comparative study on the efficacy of wound irrigation solutions in the removal of biofilm produced by MRSA bacteria on pig wounds. Tested solutions: Prontosan® solution, physiological saline and Ringer solution. MRSA bacteria were inoculated on artificiall skin wounds and after 72 hours of growth and generation of a bio- film by bacteria, the effectiveness of the mentioned solutions was tested. Only Pron- tosan® proved to be effective in eliminat- ing the biofilm and MRSA from the wound site. Both physiological saline and Ringer solution did not demonstrate a measurable effect on the wounds microbial load. Prof. Steven Davies, University of Miami, USA, 2007, unpublished data .
  7. 7. Infection control and optimal effect of therapeutics used A retrospective analysis of the healing time and healing performance of venous leg ulcers in 112 patients treated with modern wond dressings. Additionally, Prontosan® solution was used for cleansing wounds in a group of 59 patients and physiologi- cal saline or Ringer solution were used in the control group consisting of 53 patients. In the period under observation secondary infection was reported in 3% of patients from the Prontosan® group and in 13% of patients in the physiological saline/ Ringer solution group. A reduction of more than one month in the average healing time was observed: from 4.42 month in the physiological saline/ Ringer solution group to 3.31 month in the Prontosan® group. Wound healing perfor- mance in the first 3 months was over twice as high in the Prontosan® group than in the physiological saline/ Ringer solution group: 60% of wounds healed in the Prontosan® group against 28% of wounds healed in the physiological saline group. T. Eberlein et al. Die Schwester der Pfleger, 45, 9/2006, p. 2-4. Acceleration of wound healing See above (T. Eberlein) and other experi- ments:Wounds after amputation of frost- bitten toes of both feet. An example illu- strating the effect of Prontosan® solution at all stages of the TIME framework: wo- und cleansing, infection control, tissue mo- isture balance and stimulation of healing process. Fig. 1 Wounds after ca 3 months after amputation Fig. 2 The same wounds after 13 days of using Pron- tosan solution
  8. 8. Prontosan® gel Transparent, colourless, odourless, aqueous gel, free of regreasing compounds, containing: Component Description 0,1% undecylenimidopropyl surfactant ensuring cleansing effect betaine 0,1% polyaminopropyl biguanide preservative with high tissue tolerance (polyhexanide) water for injection highly purified water, solvent glycerol (glycerine) moisturising agent hydroxyethylcellulose plant-derived gelling agent Prontosan® solution Transparent, colourless, odourless, aqueous solution containing: Component Description 0,1% undecylenimidopropyl surfactant ensuring cleansing effect betaine 0,1% polyaminopropyl biguanide preservative with high tissue tolerance (polyhexanide) water for injection highly purified water, solvent Presentation Unit of Sale REF Prontosan solution6 x 40 ml ampoule 1 400 414 Prontosan solution 350 ml bottle 1 400416 Presentation Unit of Sale REF Prontosan gel 30 ml bottle 1 400 516
  9. 9. LAV-TIME effective chronic wound treatment LAVASEPSIS wound bed preparation per se TIME TISSUE MANAGEMENT INFLAMMATION/ INFECTION CONTROL MOISTURE BALANCE EPITHELIAL/EDGE/ ADVANCEMENT optimal effect of therapeutic strategies applied
  10. 10. Przedstawiciel podmiotu odpowiedzialnego: AESCULAP CHIFA Sp. z o.o. ul. Tysi¹clecia 14, 64-300 Nowy To­myœl, tel. 061 44 20 100 fax 061 44 23 936 Podmiot odpowiedzialny: B.BRAUN Medical AG Infection Control Seesatz CH-6203 Sempach-Station