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

A Study Into The Diagnostic Properties Of A New Device For Rapid Bedside Testing Of Infection In Chronic Wounds: The INFACT 2.0 study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26712
Enrollment
200
Registered
2013-03-14
Start date
2013-04-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic wounds (> 3 weeks)

Interventions

There are no interventions because this is a diagnostic study.

Sponsors

University of Graz, Austria
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
To 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.

Contacts

Public ContactJ. Palen, van der

Medisch Spectrum Twente, P.O. Box 50000

+31 (0)53 4872023

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)