Wound Infection Detection Evaluation, WIDE
Condition: Wound Infection Bacterial; Ulcer Foot; Diabetic Foot; Diagnostic Self Evaluation
MeSH terms: Infections; Communicable Diseases; Wound Infection; Bacterial Infections; Diabetic Foot; Wounds and Injuries
Study type: Observational

Summary: 
      Chronic wounds, such as diabetic foot ulcers, place a huge burden on healthcare systems and
      can lead to complications with high morbidity, particularly if the wound if infected. In
      parallel, there is pressure to reduce the use of antibiotics in order to minimise the risk of
      antimicrobial resistance. The Glycologic wound detection kit (GLYWD) is a point-of-care test,
      designed to provide guidance to clinical staff as to whether a chronic wound is infected or
      not. In this prospective cohort study the premise of this mode-of-action is evaluated. GLYWD
      will be applied in conjunction with clinical opinion and microbiological testing to determine
      if there is concordance between the different diagnostic approaches, and if applicable how
      they may differ in certain patients' wounds.
    

Detailed description: 
      The occurrence of diabetic foot ulcer (DFU) is a common complication of diabetes with
      enormous cost implications, totalling £650 million per year once associated morbidity is
      taken into account (NHS Diabetes report). Bacterial infection of wounds carries the risk of
      further degenerative complications including cellulitis, necrotising fasciitis, and sepsis
      (Grothier, 2015). Specific wounds, such as diabetic foot ulcers may lead to amputation if
      osteomyelitis develops. An additional undesirable effect of infection of wounds is that it
      delays - or stops altogether - the wound healing process (Halbert et al, 1992).

      Detection of DFU infection remains reliant on clinical judgement. For example, imaging
      modalities such as MRI do not perform better than clinical appraisal in terms of sensitivity
      and specificity when it comes to detecting osteomyelitis (Dinh et al, 2008). O'meara and
      colleagues (2006) concluded from a systematic review on clinical examination, sample
      acquisition and sample analysis in DFUs that there is a lack of evidence regarding what
      samples should be taken and how they should be analysed. They did suggest that
      semi-quantitative sample analysis - a category that the Glycologic detection kit (called
      GLYWD) would fall under - may be a useful alternative to quantitative analysis. Quantitative
      detection of infection is still undertaken by swabbing the wound and then culturing the
      pathogens in a microbiology laboratory. Obtaining these results generally takes days; even
      molecular profiling does not give an instant result. Microbiological counts and species
      identification do not necessarily reflect infection as defined by other assessments, as
      demonstrated by Gardner et al (2014).

      Clinical guidelines stipulate that the only available laboratory-based diagnostic option,
      microbiological testing, should only be used to identify the pathogen strain in clinically
      confirmed infection. Therefore, clinical opinion is the mainstay of predicting and diagnosing
      infection (NICE, 2008, 2015). The lack of a simple cost-effective and repeatable testing
      method may have three consequences: 1) lack of uniformity in diagnosis, due to differences in
      clinical judgement, which in turn may result in 2) over-diagnosis of infection with
      inappropriate prescription of antibiotics or antimicrobial dressings, or 3) late presentation
      of patients with systemic signs and spreading cellulitis or osteomyelitis requiring hospital
      admission and treatment with intravenous antibiotics or emergency surgery.

      The provision of a rapid, reliable, sensitive and relatively low cost infection detection
      test kit for infection, which can be used at point-of-care, has the potential to provide the
      NHS with significant cost savings as well as improving the outcomes for patients. Therefore,
      in this study the Glycologic diagnostic wound infection detection test (GLYWD) is evaluated
      against clinical opinion and microbiological diagnostics to determine if it is an effective
      tool for the rapid detection of chronic wound infection.
    

Intervention name(s): GLYWD
Intervention type(s): Diagnostic Test
Intervention description(s): As mentioned in the group description, GLYWD is a plastic test tube and a chromatic test that contains two solutions. When combined with a wound exudate and incubated at RT, it will change colour to red if there is a pathological bacterial wound infection present.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic non-infected Diabetic Foot Ulcers (DFU) or other chronic and
        delayed-healing wounds will be recruited into the study. Patients will be recruited from
        the adult population seen routinely by the evaluation clinical staff.