Infection Proof of Concept Study
Research type
Research Study
Full title
A Multi Centre, International, Analytical performance study of pH, HNE and MPO levels in detecting wound infection. Proof of Concept Biomarker Study. INDICATE Study
IRAS ID
294261
Contact name
Julie Nicholson
Contact email
Sponsor organisation
ConvaTec Limited
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new infection detection technology. This is based on the combined measurement of the following three biomarkers: wound pH, and activity of human neutrophil elastase (HNE) and myeloperoxidase (MPO) host enzymes. Research is emerging that demonstrates that non-healing wounds tend to have a more alkaline (higher pH) environment. Moreover, alkaline pH has been associated with wound biofilm development, which can be a precursor to wound infection. ConvaTec and partners have also recently demonstrated that wound pH seems to be a promising marker for wound infection.
The aim of this proof of concept study is to further investigate correlations between expert clinical judgment of wound infection status, and also molecular microbiological assessment of wound swab and biopsy samples with levels of the emerging infection biomarkers, pH, HNE and MPO, as measured using in vitro assays, using a larger clinical sample set collected with commercially available wound swabs.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0168
Date of REC Opinion
19 May 2021
REC opinion
Favourable Opinion