Haemoglobin spray for wound healing. Spray for treatment of chronic wounds
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1 Haemoglobin spray for wound healing Spray for treatment of chronic wounds
2 The Company The Market The Efficacy The Product Haemoglobin spray for wound healing
3 The company scientists
4 Overview Germany * Wounds Amputations *Mean value from literature, information differ between 2.5 and 6 Mio.
5 Overview Germany This costs the economy annually.
6 Overview Worldwide diabetes - number 1 public health problem 5% prevalence rate of diabetes mellitus worldwide (WHO, 2012) development of diabetic foot ulceration in 20% of the 346 million people with diabetes worldwide (WHO, 2012) Diabetes meillitus (Mio) DFS (Mio) 438 million people will suffer from diabetes by 2030, of which up to 25% may develop foot ulcera (WHO) hence 109,5 million chronic wounds just due to diabetes in 2030
7 Chronic wounds Germany Decubitus Other Wounds Secondary Healing DFS UC AVK Diagnosis Cases Diabetic foot syndrome (DFS) Artery occlusive disease (AOD) Ulcus cruris (UC) Secondary healing Other wounds Decubitus Total
8 Chronic wounds Diabetic foot syndrome (DFS) syndrome related to diabetes mellitus destruction of bones and tissue of the foot connected with polyneuropathy
9 Chronic wounds Arterial occlusive disease (AOD) Disturbance of peripheral arterial circulation of extremeties arteriosclerosis narrowing (stenosis) or closure (occlusion) of supplying artery
10 Chronic wounds Ulcus cruris (UC) Ulcer on the lower leg Types: ulcus cruris venosum, mixtum, arteriosum and more Frequent cause: chronic venous insufficiency (venous weakness)
11 Chronic wounds Decubitus Decubitus ulcer, bedsores locally limited damage to the skin and/or the underlying tissue Cause: bedsore/ lying in one spot for a long period of time
12 Hospital and ambulatory care only 5% of all treatments take place within hospitals 95% are dependent on ambulatory, home care inpatients outpatients
13 Main functions of wound care products: 1. moisture management 2. protection illustration from the book: Vasel-Biergans, Anette Wundauflagen für die Kitteltasche
14 Why is this situation still the same after so many years? because all allegedly innovations are missing at least one important target! To change this situation fundamentally, the treatment approaches have to be: effective available for ambulatory care affordable for patients, treating physicians and health insurances.
15 Key success factors Effectiveness Quicker and better healing than existing concepts, also for stagnant wounds. Availability To make products available for ambulant care it has to be ensured that the acquisition costs of required materials and utensils, treatment time per procedure, transportability of the necessary materials and the training expense of the implementing personnel for mobile nursing services are supportable. Affordability Treatment costs within a frame, which can be financed permanently by benefactors within the healthcare system.
16 Joint aetiology different primary diseases lead to a circulatory disorder this results in a local oxygen deficit (hypoxia) almost all chronic wounds are hypoxic Especially wounds need a lot of oxygen! massive tissue formation, division of cells, immunoactivity require significantly more oxygen metabolism activity within a wound than within intact tissue the required additional energy is provided by consumption of oxygen. the oxygen demand increases! If the wound is missing oxygen, healing or regeneration processes are not taking place or only delayed!
17 Abhängigkeit verschiedener Stoffwechselprozesse von der Sauerstoffsättigung
18 Consequence: Stagnation of the woundhealing in the case of hypoxia injury / wound inflammation proliferation / granulation TcPO2 << 30mmHg healing stagnation hours days month weeks collagen III synthesis fibronectin synthesis collagen I increase the elasticity neutrophil Myofibroblasts macrophages Fibroblast
19 >> Wound healing requires hypoxia control.<< George D. Winter
20 Hypoxia Background Problem: Partial pressure of oxygen is insufficient cells need at least 20 mm Hg to survive (minimum) complex metabolism activities, especially wound closure / granulation require a minimum of 40 mmhg normal condition Most chronic wounds are in this area critical zone, wound healing impossible the tissue dies in most cases Partial pressure of oxygen in mmhg
21 Hypoxia Treatment options improvement of oxygen supply due to improvement of blood circulation within the frame of an adequate causal therapy Oxygen is provided from the inside. additional support by oxygen supply from the outside Oxygen from the air has to be made available for cellular activity at the base of the wound.
22 Oxygen barrier The exudate presents a diffusion barrier for oxygen. Already a liquid film of 20 micrometer blocks 95% of the diffusion. Even though sufficient oxygen is available within the air, it can t get to the base of the wound due to the diffusion barrier. Therefore the oxygen requirement of the cells can t be fulfilled. Modified equation by Einstein and Smoluchowski 20 Distance of source x
23 Bild aus Keynote Speech
24 Oxygen barrier The exudate prevents the supply of oxygen from the surrounding air to the base of the wound.
25 Principle of haemoglobin use of a natural oxygen transporter transporter takes oxygen from the surface down to the base of the wound unloading at the base of the wound transporter takes again oxygen from the surface rotating procedure Principle of simplified diffusion!
26 Principle of Haemoglobin Haemoglobin as transport molecule takes oxygen to the base of the wound.
27 1 g hemoglobin transports 1 liter oxygen within one day 1
28 Granulox Legal status the principle of facilitated diffusion is solely physical neither a pharmacologic nor an immunologic or a metabolic effect takes place there is no interaction with a cellular component therefore the product is Medical Device Class III
29 Easy use 1. cleaning/flushing of wound 2. application of Granulox 3. covering of wound area
30 Granulox Suitable wound dressings hydropolymer dressings / foam dressings adhesive / nonadhesive with and without silicone coating spacer grids superabsorbents/ hydrofibres Tegaderm Foam, 3M Mepilex, Mölnlycke Tielle, Sytagenix Allevyn, Smith&Nephew Cutimed, BSN UrgoCell, Urgo Hydro Tac, Hartmann Suprasorb P, Lohmann&Rauscher Biatain, Coloplast Adaptic, Sytagenix UrgoTül, Urgo Aqualcel, ConvaTec Cutisorb Ultra, BSN Suprasorb X, Lohmann&Rauscher
31 Granulox limited suitable dressings hydrogels film dressings alginates NuGel, Systagenix UrgoHydrogel, Urgo Intrasite Gel, Smith&Nephew Hydrosorb Gel, Hartmann Purilon, Coloplast Tegaderm Film, 3M Bioclusive, Systagenix Sorbalgon, Hartmann Trionic, Systagenix Melgisorb, Mölnlycke Cutimed Alignat, BSN Kaltostat, ConvaTec
32 Granulox Unsuitable wound dressings Hydrocolloid dressings Occlusive film dressings VAC-systems
33 Available? YES!
34 Studies confirm the efficacy of this treatment approach!
35 Inclusion criteria patients > 18 years ulcus cruris venosum > 8 weeks wound area > 2,5 cm 2 < 50 cm 2 ABI > 0,8 (ankle brachial index) Additional diagnostic measures for characterization of patients: ultrasound duplex scan and foot pulse measure hospitalisation for 2 weeks treatment according to current hospital therapeutic schedule incl. compression* before inclusion until start of treatment during the day: compression therapy perputation of the compression therapy during the whole treatment period - integral part and monitored compression bandages with fairly high compression pressure through a constant perimeter at the ankle no treatment success = inclusion T 0 of treatment treatment success = no inclusion, continuing the therapy
36 Results
37 Absolute & percentage change of the wound area Continuous reduction of the wound size during the treatment period in the hemoglobin group.
38 Results Significant reduction of wound size by using hemoglobin spray; in comparison to the control group average 53% (p<0,0001) 38
39 Examples of application Male patients; 43 years; for 8 years relapsed undulant ulcer Period of treatment: 1. half year 2012 Treatment location: Pflegedienst Duisburg, Germany start 4 weeks 15 weeks 10 weeks Today the wound is healed totally Before the treatment with Granulox the patient opposed a recommendation for amputation.
40 Examples of application Male patient; 58 years Ulcus cruris on the lower left leg; CVI; Diabetes mellitus Period of treatment: 1. half year 2012 Treatment location : Krankenhaus Nordwest, Frankfurt a.m., Germany start 2 weeks 7 weeks 4 weeks
41 Effective? YES!
42 Affordable? can sufficient for approx. 30 uses costs per use between 2 and 4 in Germany
43 Influence of Granulox on speed of healing.
44 Comparison of healing speed Absolute decrease of wound size in mm² per day , * 1 0 Hydroaktiv hydroactive Granulox Granulox *Mean value from literature
45 Comparison of healing speed Study Result The healing speed of Granulox is with a wound decrease of 9,3mm² per day three times as quick as with hydroactive treatment. Economic View For reasons of care a 33,33% safety margin is taken into account and the healing speed is considered only twice as high.
46 Economy *971,14 50% quicker healing time 40% decrease total costs *110 days 583, *61,80 55 days 74, Heilungsdauer healing time Kosten/Woche costs/week Gesamtkosten total costs Heilungsdauer healing time Kosten/Woche costs/week Gesamtkosten total costs Hydroaktive Hydroaktive + Granulox *Source: Augustin et al. 1999
47 Klinikum München Pasing The clinical center Munich Pasing is an efficient clinical center with space for 430 patients with focus on specialised medical services. Comprehensive modern diagnostic and therapeutic facilities as the best option for an individual care in the specialised departments. approximately 550 patients with chronic wounds per annum costs per annum for wound care (not included: vacuum therapy and maggot therapy)
48 Case Study 1 patient: primary disease: wound: male, 74 years paod, stage IV according to Fontaine ulcus cruris arteriosum lower leg (left) Wound treatment before Granulox : amorphous gel collagen protection of wound edges superabsorbent UAW Dressing change cycle: 2-3 per week
49 Case study 1: Costs per dressing without Granulox with Granulox material costs material costs amorphous gel 1,36 Granulox 5,32 collagen 7,98 absorbent dressing 3,18 superabsorbent 5,37 protection of wound edges 1,08 sum 15,79 sum 8,50
50 Case stuy 1: Total treatment costs
51 Case Study 2 patient: primary disease: wound: male, 75 years chronic venous insufficiency III acoording to Widmer ulcus cruris venosum, lower leg (left) Wound treatment before Granulox : amorphous gel Drainage-able PU foam dressing protection of wound edges Debrisoft Dressing change cycle: 2-3 per week
52 Case study 2: Costs per dressing Without Granulox With Granulox material costs material costs silver-calcium alginate 5,12 Granulox 7,98 PU-foam dressing 10,33 PU-foam dressing (changing only every 4th day) 10,33 protection of wound edges 1,08 Sum 16,53 Sum 18,31
53 Case study 2: Total medical costs
54 Affordable? YES!
55 Summary Effective Superior Affordable Cost-cutting Available Ubiquitary
56 Spray for treatment of chronic wounds Granulox succeeds to improve the oxygen supply of chronic wounds and to support the granulation of new tissue. Granulox an effective addition to causal therapy.
57 GRANULOX a brand of SastoMED GmbH info@sastomed.de
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