search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A study into a new test for the rapid diagnosis of a wound infection in wounds with prolonged existance: The InFact 2.0 study.


- candidate number14519
- NTR NumberNTR3904
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mrt-2013
- Secondary IDsNL43733.044.13 CCMO
- Public TitleA study into a new test for the rapid diagnosis of a wound infection in wounds with prolonged existance: The InFact 2.0 study.
- Scientific TitleA Study Into The Diagnostic Properties Of A New Device For Rapid Bedside Testing Of Infection In Chronic Wounds: The INFACT 2.0 study.
- ACRONYMINFACT 2
- hypothesisThe current diagnostic methods to identify infection in chronic wounds are based on clinical judgment and, when wound infection is suspected, a wound swab for microbiological analysis. The gold standard, wound biopsy, is only used in rare cases. However, these current diagnostic methods seem unreliable (clinical judgment) or provide results only after a couple of days (cultures). Late diagnosis of wound infection can result in hospitalization and, in worst cases, sepsis. A new diagnostic tool, the InFact, is based on the identification of the enzymes myeloperoxidase, human neutrophil elastase and lysozyme that are proven to play a role in the inflammation process. Using these enzyme analyses has the potential to detect wound infection both fast and accurate. The primary objective of the study is to determine sensitivity, specificity, positive and negative predictive value of the enzyme analyses, with wound biopsies as the gold standard.
- Healt Condition(s) or Problem(s) studiedChronic wound
- Inclusion criteria1. Open chronic wound (>3 weeks); this will be mainly:
A. Diabetic foot ulcer;
B. Ulcus cruris (arterial or venous);
C. Decubitus ulcer;
D. Operation wounds, healed by secundary intention or wound dehiscention.
2. ≥ 18 years of age;
3. Patients from the department of Surgery or Dermatology.
- Exclusion criteria1. Use of antibiotics in the last five days;
2. Malignant wounds;
3. Fully necrotic wounds;
4. Fully dry wounds; no production of wound fluid in last 2 days;
5. Allergy or hypersensitivity for Lidocaine, when local anaesthesia is necessary;
6. Wounds that are completely covered with exposed periosteum;
7. Wounds with a diameter < 2 millimeters;
8. Facial wounds;
9. Haematological disorders with risk of uncontrolled bleeding.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2013
- planned closingdate30-jun-2013
- Target number of participants200
- InterventionsThere are no interventions because this is a diagnostic study.
- Primary outcomeSensitivity, specificity, positive and negative predictive value and the AUC of the enzyme analyses with wound biopsies as gold standard are the main study parameters.
- Secondary outcomeTo determine the clinical relevance of the enzyme analyses, the diagnostic properties of both wound swab and clinical judgment, when compared to wound biopsies, will be calculated.

Furthermore, the enzyme analyses should point out what enzymes are present in the wound fluid. The types of bacteria that causes the infection is identified from wound biopsy.
- TimepointsTo determine the diagnostic properties of the enzym analyses; both a wound swab for enzymanalyses and a biopsy for microbiological analyses will be taken as a one-time assessment during the patient's regular appointment at the hospital.

To determine the clinical relevance of the enzyme analyses, the wound will be assessed through clinical judgment and a wound swab for microbiological analysis.

These four diagnostic tests will be performed during the regular appointment in the following order:
1. Clinical judgment of the wound;
2. Wound swab for enzyme analyses;
3. Wound swab for microbiological analysis;
4. Biopsy.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. J. Palen, van der
- CONTACT for SCIENTIFIC QUERIESProf. dr. J. Palen, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
University of Graz, Austria
- PublicationsN/A
- Brief summaryRationale:
The current diagnostic methods to identify infection in chronic wounds are based on clinical judgment and, when wound infection is suspected, a wound swab for microbiological analysis. The gold standard, wound biopsy, is only used in rare cases. However, these current diagnostic methods seem unreliable (clinical judgment) or provide results only after a couple of days (cultures). Late diagnosis of wound infection can result in hospitalization and, in worst cases, sepsis. A new diagnostic tool, the InFact, is based on the identification of the enzymes myeloperoxidase, human neutrophil elastase and lysozyme that are proven to play a role in the inflammation process. Using these enzyme analyses has the potential to detect wound infection both fast and accurate.

Objective:
The primary objective of the study is to determine sensitivity, specificity, positive and negative predictive value of the enzyme analyses (myeloperoxidase, human neutrophil elastase and lysozyme) with wound biopsies as the gold standard. Furthermore, microbiological analysis based on wound swabs and the clinical judgment will be compared with the biopsy results.

Study design:
This diagnostic study is designed as a cross-sectional study.

Study population:
The study population consist of adult patients (≥ 18 years) with chronic wounds, presenting at the departments of dermatology and vascular surgery of the Medisch Spectrum Twente Hospital, Enschede.

Main study parameters/endpoints:
Sensitivity, specificity, positive and negative predictive value and the AUC of the enzyme analyses with wound biopsies as gold standard are the main study parameters.
- Main changes (audit trail)
- RECORD14-mrt-2013 - 25-mrt-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl