Clinical trial NCT04507724: The Use of Biochemical Analyzes to Monitor the Development of Wounds
Official title: The Use of Biochemical Analyzes to Monitor the Development of Wounds: Part 1: Analysis of Wounds Without VAC Therapy: Part 2: Analysis of Wound Fluids Under VAC Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound
Wound Infection
Wound Contamination
Diagnostic Techniques and Procedures
Negative Pressure Wound Therapy
Biomarker
Keywords: wound infection
negative pressure wound therapy
diagnostic tool
biomarker
Lead sponsor: Qualizyme Diagnostics GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 41
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 cohort will be selected by inpatients with wounds (part 1) or with negative pressure wound therapy (part 2)

Brief summary: Chronic wounds represent a growing challenge in medical care.

Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display an infection prematurely. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) measured overed 3 days, would indicate a change in the wound bed (infection, Inflammation) earlier than the regularly performed clinical assessment.

Part 2: The aim of this part of the study was to evaluate (I) the possibility of wound fluid acquisition by means of an "additional collector" during ongoing NPWT and to answer if (II) this secretion can be biochemically analyzed for enzyme activities in order to be able to detect a change in the wound situation at an early stage.

Detailed description: The study is composed of two parts, which run independently of each other. However, in both parts the course of the wounds is analyzed.

Part 1: Two wound swabs are taken. One used for routinely performed microbiological analysis and the second will be used for biochemical analysis (enzyme activities). The aim of the wound swabs is to answer the question whether the rapid diagnostic tool used in the examination can display an infection prematurely or not. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) would indicate a change in the wound bed (infection, inflammation) earlier than the regular clinical assessment. These wound swabs are expected to function as an improvement of the biochemical assays or rather of the technology concerning sensitivity and specificity of, for example, the pH number, the MPO, the LYS, the gelatinase and the elastase. In addition to that, the correlation between the Enzyme activities and the course of the infection will be examined. This technology is supposed to be later used as an early infection diagnostic tool in wound fluids. The followup of this testing system is a crucial prerequisite for the application of the technology in VAC therapy (part 2).

Part 2: The findings of this examination will be used to investigate the applicability of the developed in-vitro early infection diagnostic tool in negative-pressure therapy (VAC therapy; vacuum assisted closure).

Patients of the plastic surgery with a NPWT are included in this prospective study. Before the NPWT will be applied, two swabs (biochemical and microbiological analysis) of the wounds will be taken. After installation of the dressing, the connecting tube between the wound and the vacuum-generating device will be cut and an "additional collector" will be inserted. This collector will be changed daily and afterwards the concentrations of enzymes (lysozyme, elastase, myeloperoxidase) will be biochemically analyzed.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* older than 18 years old
* open wound of varying etiology
* VAC therapy (KCI) (part 2)

Exclusion Criteria:

* under 18 years old
* pregnant women
* less than three measurement data (less than three swabs) = part 1
* VAC-instill therapy = part 2

Primary outcomes:
measure: Part 1: biochemical analysis of wounds
timeFrame: during hospitalization
measure: Part 2: Descriptive assessment of the feasibility of collecting wound fluid during ongoing negative pressure wound therapy
timeFrame: during negative pressure wound therapy
Secondary outcomes:
measure: Part 2: Evaluating changes in enzyme activities in the collected wound fluid
timeFrame: Starting immediately after installation of the negative-pressure dressing and lasting for 3 days.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Michael Schintler, Prof.
role: PRINCIPAL_INVESTIGATOR
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