SPaCE Pilot
Research type
Research Study
Full title
Pilot study to investigate the use of SPaCE phospholipid vesicle technology: a point of care tool to aid diagnosis for detection of clinically relevant burn wound infection. ‘Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans and Enterococcus faecalis: The SPaCE pathogens.’
IRAS ID
260069
Contact name
Amber Young
Contact email
Sponsor organisation
University Hospitals Bristol NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 2 days
Research summary
Summary of Research
Burn wound infections are difficult to diagnose. When infection is suspected, a swab is usually taken of the wound and sent to be tested for pathogens. Results usually take 24 to 48 hours. The SPaCE-swab sensor kit is a low cost, fast, near-to-patient method that aims to assess whether a wound is infected or not. The kit can be utilised when wounds are swabbed as part of standard care. The swab would be placed in the patented vesicle gel, left for a minimum of 60 minutes and observed for any colour change. If the tube containing the test solution and the patient swab changes colour to a bright green this indicates a positive result 'switch on' of the solution. This study will look at the correlation of clinical diagnosis of wound infection and that indicated by the SPaCE sensor 'switch on'.
This project could lead to a near-to-patient, low cost and rapid wound swab sensing kit which can be used immediately in secondary care settings and has the potential for long-term use in primary care settings and in low-resource settings.Both adults and children with and without infected burn wounds, who attend one of three participating Burns Services will be asked to participate. Participants will be asked for swab samples to be taken. Information will be recorded from participants’ notes about their health, care, suspected presence of infection and need for antibiotics. Participants will be followed-up within 21 days, through a notes review, looking at their wound healing and health status.
Summary of Results
Background: Wound infection in burn patients is common effects on outcomes. There is no objective method to diagnose infection at point of patient care (PoC). Early diagnosis prevents progression to sepsis. Diagnostic difficulty may lead to over-diagnosis, unnecessary hospitalization, and antibiotic overuse.
Aim: This pilot study aimed to investigate the accuracy of a novel PoC wound infection diagnostic in burn patients.
Methods: We produced, and tested, a PoC diagnostic for early wound infection diagnosis. The prototype SPaCE diagnostic uses a suspension into which a clinical swab is placed. The suspension causes a colour-response to common bacteria found in wounds and the points of toxin release and harm to patients and the wound. A pilot clinical diagnostic accuracy study was undertaken. The reference standard was a retrospective decision made by an expert clinical panel using routinely available data.
Findings: Data was available from 33 of 34 patients. Of these, 52% were considered to have a wound infection, 42% not, and two (6%) were equivocal. The diagnostic results showed 24% were infected, 42% were not and 33% produced intermediate results. Agreement between clinical judgement and diagnostic result, assessed using statistical analysis, was 0.591 suggesting moderate agreement. If the intermediate results were excluded, 22 sets of data with definitive results achieved a Kappa statistic of 0.81 suggesting ‘almost perfect’ agreement. Sensitivity and specificity were 57% (8/14) and 71% (12/17), respectively.
Conclusion: This pilot study provided evidence that the SPaCE diagnostic could provide valuable and timely data to support clinical decision-making at PoC for wound infectionREC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0200
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion