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In the western industrialized countries, about 2% of the population suffers from chronic wounds. Decubitus wounds, ulcus cruris and diabetic feet are the most frequent types of chronic wounds, mostly associated with age. Demographic trends show a significantly increased life expectancy, combined with growth in chronically ill and health-care dependent people. Wound infection is a global problem affecting up to 10% of post-operative wounds and about 25% of chronic wounds leading to additional costs of EUR 23 billion per year in Europe alone.

Infection is a severe complication of the wound healing process and, even in the best case with healing of the infected wound, the process is slow and accompanied by chronic pain and deterioration of patients’ quality of life.

Early identification of an infection is therefore critical. The diagnosis of wound infection in an initial stage enables a simplified and inexpensive treatment protocol preventing the establishment of pathogens in the wound and avoiding prolonged antibiotic therapy.

The current diagnosis of wound infection relies mainly on the judgment of the classical signs of infectionrelated to the inflammatory process(1,2). Some wounds are clearly infected having purulent secretions and the manifestations of inflammation (rubor (redness), calor (heat), tumor (swelling) and dolor (pain).

However, these signs of infection cannot generally be used for reliable infection assessment(3). For example, the inflammatory response to infection in diabetics can be reduced by vascular disease and neuropathy(4). Neuropathy may obscure or cause pain. Ischemia may reduce erythema, warmth, or induration, and venous insufficiency may mask warmth or cause induration. Gardner et al(5) concluded that the individual clinical signs of infection do not perform well in the overall infection diagnosis. This can result in undetected infections or unnecessary use of antibiotics leading to antimicrobial resistance.

If clinical signs suggest infection, a common method for evaluation of wound infection is superficial wound swabbing(6). Swabs are analyzed for identification of microorganisms by cultivation in specialized labs. A disadvantage of this method is that non-pathogenic colonizing microorganisms are also measured. Results of the analysis are available over a period of days depending on the organism. This is slow, expensive, indefinite and inefficient especially for incipient infection. Moreover it requires trained personal and analytical equipment/labs.

A quantitative method of infection detection is the tissue biopsy - the ‘gold standard’ in medical practice(7). This method, however, is not routinely used due to the patient burden - it requires surgical sampling of the wound tissue. Moreover, biopsies or swabs are applied only when the clinical signs of infection are apparent, meaning late diagnosis and treatment. The time lost in culturing of the microorganisms is a major disadvantage of the biopsy-based test.

In contrast, InFact aims to bring to the market an entirely novel approach for wound status monitoring as a complementary tool in an efficient treatment strategy. The new class of in situ diagnostic materials will be able to define the wound infection related signal faster than normal. The positive signals will indicate the type of treatment to be applied and the need for a dressing change.

1. D. Krasner, Chronic Wound Care: A Clinical Source Book for Professionals, Health Management Publications, 1997

2. N.A. Stotts and T.K. Hunt, Managing Bacterial Colonization and Infection, Clin. Geriatr. Med, 13 (1997), 565-573.

3. R.G. Sibbald, H. Orsted, G.S. Schultz, P. Coutts, and D. Keast, Preparing the Wound Bed 2003: Focus on Infection and Inflammation, Ostomy.Wound Manage. 49 (2003) , 23-51.

4. Pozzili P, Leslie RD. Infections and diabetes: mechanisms and prospects for prevention. Diabet Med 1994;11:935-41

5. Gardner et al.  Clinical Signs of Infection in Diabetic Foot Ulcers With High Microbial Load Biol Res Nurs 2009:11:119 

6. H. Rode, I.D.O. Vale, and A.J.W. Millar, Infection is one of the Commonest Causes of Death in Burn Patients, Particularly those with Extensive Damage, Cont.Med.Edu. (2008)

7. Robson MC, Heggars JP. Bacterial quantification of open wounds, Mil Med. 1969;134:19-24.

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