A study into a new test for the rapid diagnosis of a wound infection in wounds with prolonged existance: The InFact 2.0 study.
- Conditions
- Chronic wounds (> 3 weeks)
- Registration Number
- NL-OMON26712
- Lead Sponsor
- niversity of Graz, Austria
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Open chronic wound (>3 weeks); this will be mainly:
A. Diabetic foot ulcer;
Exclusion Criteria
1. Use of antibiotics in the last five days;
2. Malignant wounds;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. <br><br /><br /><br>Furthermore, the enzyme analyses should point out what enzymes are present in the wound fluid. <br>The types of bacteria that causes the infection is identified from wound biopsy.