Wound Infection Detection Test
Research type
Research Study
Full title
A pilot study to evaluate the accuracy of a novel infection detection test in the management of chronic wounds.
IRAS ID
198718
Contact name
Richard Tester
Contact email
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Currently, there is no single test to definitively diagnose wound infection. Clinicians accomplish wound diagnosis through visual inspection of wounds. Thus, there is no objective qualitative and quantitative data available at the point
of care to make rapid diagnostic decisions.Diagnostic tests typically require a wound fluid sample to be sent to a central laboratory with a turnaround time of results of 24 hours or longer (especially considering the majority of wounds are managed in the community setting by non-specialist nurses).
An early diagnosis of wound infection would enable clinicians to manage wounds more effectively, enabling the appropriate use of antimicrobials. This study proposes that biochemical markers within the wound can be used as predictive markers for wound infection. The aim of this pilot study is to understand whether a novel wound infection test at the point of care can be used to predict wound infection as diagnosed by a clinician over an 10 week period.
A total of 12 patients will be recruited.
The primary objective is to assess the efficacy of the novel infection diagnostic test kit over a 10 week period by comparing the results of the test kit with the clinician’s assessment of wound infection.
At each assessment, the patient will have:
i) clinician's visual assessment of wound infection
ii) a swab of the wound for the novel test kit
iii) standard treatment/dressing applied
The study is designed as a pilot study to determine feasibility with the view to conducting further larger trials.REC name
London - Queen Square Research Ethics Committee
REC reference
16/LO/0219
Date of REC Opinion
26 Jan 2016
REC opinion
Favourable Opinion