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WoundNPWWNCT04507724

The Use of Biochemical Analyzes to Monitor the Development of Wounds

An observational study of Wound and Wound Infection, run by Qualizyme Diagnostics GmbH & Co KG at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wound, Wound Infection, Wound Contamination
How many people
41 participants
Where
1 siteAustria
Study dates
19 Oct 2018to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The cohort will be selected by inpatients with wounds (part 1) or with negative pressure wound therapy (part 2)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

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

    Graz, 8010

Other trials in Austria

About this study

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

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.

Read the 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.

Keywords
wound infection, negative pressure wound therapy, diagnostic tool, biomarker
Medical subject headings
Wounds and Injuries, Wound Infection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: biochemical analysis of wounds

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

    Measured: during hospitalization

  2. Part 2: Descriptive assessment of the feasibility of collecting wound fluid during ongoing 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.

    Measured: during negative pressure wound therapy

Secondary outcomes (1)

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

    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"

    Measured: Starting immediately after installation of the negative-pressure dressing and lasting for 3 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start19 Oct 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04507724
Sponsor's protocol ID
NPWW
Acronym
NPWW
Status last verified
May 2021
First submitted
22 Jul 2020
Last updated
18 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • McDaniel JC, Roy S, Wilgus TA. Neutrophil activity in chronic venous leg ulcers--a target for therapy? Wound Repair Regen. 2013 May-Jun;21(3):339-51. doi: 10.1111/wrr.12036. Epub 2013 Mar 28.

    PubMed 23551462

  • Trengove NJ, Bielefeldt-Ohmann H, Stacey MC. Mitogenic activity and cytokine levels in non-healing and healing chronic leg ulcers. Wound Repair Regen. 2000 Jan-Feb;8(1):13-25. doi: 10.1046/j.1524-475x.2000.00013.x.

    PubMed 10760211

  • Ladwig GP, Robson MC, Liu R, Kuhn MA, Muir DF, Schultz GS. Ratios of activated matrix metalloproteinase-9 to tissue inhibitor of matrix metalloproteinase-1 in wound fluids are inversely correlated with healing of pressure ulcers. Wound Repair Regen. 2002 Jan-Feb;10(1):26-37. doi: 10.1046/j.1524-475x.2002.10903.x.

    PubMed 11983004

  • Yager DR, Zhang LY, Liang HX, Diegelmann RF, Cohen IK. Wound fluids from human pressure ulcers contain elevated matrix metalloproteinase levels and activity compared to surgical wound fluids. J Invest Dermatol. 1996 Nov;107(5):743-8. doi: 10.1111/1523-1747.ep12365637.

    PubMed 8875960

  • Izadi K, Ganchi P. Chronic wounds. Clin Plast Surg. 2005 Apr;32(2):209-22. doi: 10.1016/j.cps.2004.11.011.

    PubMed 15814118

  • Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.

    PubMed 9188971

  • James GA, Swogger E, Wolcott R, Pulcini Ed, Secor P, Sestrich J, Costerton JW, Stewart PS. Biofilms in chronic wounds. Wound Repair Regen. 2008 Jan-Feb;16(1):37-44. doi: 10.1111/j.1524-475X.2007.00321.x. Epub 2007 Dec 13.

    PubMed 18086294

  • Steenvoorde P, van Engeland A, Oskam J. Vacuum-assisted closure therapy and oral anticoagulation therapy. Plast Reconstr Surg. 2004 Jun;113(7):2220-1. doi: 10.1097/01.prs.0000123603.32963.11. No abstract available.

    PubMed 15253223

  • Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.

    PubMed 9188970

  • Huang C, Leavitt T, Bayer LR, Orgill DP. Effect of negative pressure wound therapy on wound healing. Curr Probl Surg. 2014 Jul;51(7):301-31. doi: 10.1067/j.cpsurg.2014.04.001. Epub 2014 Apr 26.

    PubMed 24935079

  • Nuutila K, Yang L, Broomhead M, Proppe K, Eriksson E. Novel negative pressure wound therapy device without foam or gauze is effective at -50 mmHg. Wound Repair Regen. 2019 Mar;27(2):162-169. doi: 10.1111/wrr.3. Epub 2018 Oct 31.

    PubMed 30378215

  • Isago T, Nozaki M, Kikuchi Y, Honda T, Nakazawa H. Effects of different negative pressures on reduction of wounds in negative pressure dressings. J Dermatol. 2003 Aug;30(8):596-601. doi: 10.1111/j.1346-8138.2003.tb00441.x.

    PubMed 12928528

  • Fleischmann W, Russ M, Westhauser A, Stampehl M. [Vacuum sealing as carrier system for controlled local drug administration in wound infection]. Unfallchirurg. 1998 Aug;101(8):649-54. doi: 10.1007/s001130050318. German.

    PubMed 9782769

  • Timmers MS, Graafland N, Bernards AT, Nelissen RG, van Dissel JT, Jukema GN. Negative pressure wound treatment with polyvinyl alcohol foam and polyhexanide antiseptic solution instillation in posttraumatic osteomyelitis. Wound Repair Regen. 2009 Mar-Apr;17(2):278-86. doi: 10.1111/j.1524-475X.2009.00458.x.

    PubMed 19320897

  • Blokhuis-Arkes MH, Haalboom M, van der Palen J, Heinzle A, Sigl E, Guebitz G, Beuk R. Rapid enzyme analysis as a diagnostic tool for wound infection: Comparison between clinical judgment, microbiological analysis, and enzyme analysis. Wound Repair Regen. 2015 May-Jun;23(3):345-52. doi: 10.1111/wrr.12282. Epub 2015 Jun 19.

    PubMed 25816836

Questions about this trial

What is this clinical trial studying?

An observational study of Wound and Wound Infection, run by Qualizyme Diagnostics GmbH & Co KG at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: biochemical analysis of wounds (time frame: during hospitalization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04507724, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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