The Use of Biochemical Analyzes to Monitor the Development of Wounds (NPWW)

May 17, 2021 updated by: Christina Helene Wolfsberger, Qualizyme Diagnostics GmbH & Co KG

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: biochemical analysis of wounds
Time Frame: during hospitalization
Elevated enzyme activities (biochemical analysis of wound swabs) give information of the condition of the wound bed (infection, inflammation).
during hospitalization
Part 2: Descriptive assessment of the feasibility of collecting wound fluid during ongoing negative pressure wound therapy
Time Frame: during negative pressure wound therapy
The aim is to answer the question if it is feasible to collect wound fluid during ongoing negative pressure wound therapy and analyze this wound fluid biochemically.
during negative pressure wound therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 2: Evaluating changes in enzyme activities in the collected wound fluid
Time Frame: Starting immediately after installation of the negative-pressure dressing and lasting for 3 days.
The collected wound fluid will be analyzed biochemically daily over three days. This might give as informations of wounds as an "in-vitro early infection diagnostic tool"
Starting immediately after installation of the negative-pressure dressing and lasting for 3 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qualizyme Diagnostics GmbH & Co KG

Investigators

  • Principal Investigator: Michael Schintler, Prof., Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 19, 2018

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

August 9, 2020

First Posted (ACTUAL)

August 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPWW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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