NCT04979637

Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study

A Multi Centre, International, Analytical Performance Study of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy.

Detailed description

One of the biggest challenges in wound care today is the accurate and timely diagnosis of infection in complex wounds. Despite efforts, it still remains difficult to determine whether complex wounds are infected or not. There is no single gold standard for wound infection: clinicians use a multitude of methods in addition to the history and their examination to reach an overall conclusion as to potential wound infection status - each with its own strengths and weaknesses (associated performance characteristics). To aid accurate and timely detection of wound infection in clinical practice, ConvaTec and partners have developed a new technology intended to detect infection biomarkers. 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. The overall aim of this proof of concept study is to demonstrate that the three infection biomarkers (HNE/MPO/pH) surpass clinical judgement in detecting infection status using a standard of reference. The primary objective of the proof of concept study is to demonstrate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a wound biopsy. The secondary objective of the proof of concept study is to explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.

Conditions

• Wound Infection
• Wound Heal

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-11-01
• Completion: 2021-12-23
• First posted: 2021-07-28
• Last updated: 2022-10-07