Clinical trial NCT04979637: Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
Official title: A Multi Centre, International, Analytical Performance Study of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Wound Infection
Wound Heal
Keywords: diabetic foot
pressure ulcer
varicose ulcer
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
name: Qualizyme Diagnostics GmbH & Co KG
name: Perfectus BioMed
name: Welsh Wound Innovation Centre
name: Maison de Santé Protestante de Bordeaux
First posted: 2021-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of eligible patients attending their regular wound care appointment with a Health Care Professional in a Clinical setting.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects with an exuding chronic wound, presenting at study sites or associated clinical or home setting
* Aged 18 years and over
* Subjects who are able and willing to provide informed consent.

Exclusion Criteria:

* Subjects with a wound in which it is not possible to take a wound swab:
* Wounds ≤ 2 cm2 in diameter.
* Subjects who are taking or have taken systemic antibiotics in the previous 7 days
* Wounds with scant or no exudate
* Wounds that do not have sufficient exudate to complete swab collection
* Wounds where the wound bed consists predominantly of exposed bone.
* Subjects currently confirmed positive for Methicillin-resistant Staphylococcus aureus (MRSA), extended spectrum beta-lactamase (ESBL) producing bacteria, Human immunodeficiency virus (HIV), hepatitis or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
* Subjects on immunosuppressive or cytotoxic drugs
* Anticoagulated patients who cannot undergo wound biopsy

Primary outcomes:
measure: Effectiveness of the combination of 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
timeFrame: Day 28
Secondary outcomes:
measure: Explore the relationship between molecular microbiological analysis of swab samples and wound biopsies with the biomarkers pH, HNE and MPO.
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Welsh Wound Innovation Centre
name: Nicky Irvins
role: PRINCIPAL_INVESTIGATOR
References: