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NPWW: The Use of Biochemical Analyzes to Monitor the Development of Wounds

Sponsor
Qualizyme Diagnostics GmbH & Co KG (Industry)
Overall Status
Completed
CT.gov ID
NCT04507724
Collaborator
(none)
41
Enrollment
1
Location
26.4
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    41 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Oct 19, 2018
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: biochemical analysis of wounds [during hospitalization]

      Elevated enzyme activities (biochemical analysis of wound swabs) give information of the condition of the wound bed (infection, inflammation).

    2. Part 2: Descriptive assessment of the feasibility of collecting wound fluid during ongoing negative pressure wound therapy [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.

    Secondary Outcome Measures

    1. Part 2: Evaluating changes in enzyme activities in the collected wound fluid [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"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz Graz Austria 8010

    Sponsors and Collaborators

    • Qualizyme Diagnostics GmbH & Co KG

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Christina Helene Wolfsberger, Sub-Investigator, Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT04507724
    Other Study ID Numbers:
    • NPWW
    First Posted:
    Aug 11, 2020
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Christina Helene Wolfsberger, Sub-Investigator, Medical University of Graz
    wound infection
    negative pressure wound therapy
    diagnostic tool
    biomarker
    Additional relevant MeSH terms:
    Wound Infection
    Wounds and Injuries

    Study Results

    No Results Posted as of May 18, 2021