Woundchek Laboratories BV
The purpose of this clinical study is to evaluate the performance of WOUNDCHEK™ Bacterial Status (WCBS) when the test result is used to inform treatment decisions.
The clinician treating the wound will be allowed to use the test result in treatment decisions. The pretest treatment plan will be documented on the Case Report Form (CRF) prior to performing the WCBS test. After receiving the test result the clinician will document the post-test treatment plan. The healing outcome at 12 weeks following the test will be recorded on the CRF. The study will evaluate the healing outcomes compared to when test results are not used to assist in treatment decisions with study success defined as a higher healing rate and/or mean wound size reduction for WCBS positive…
Inclusion Criteria: 1. Subject has presented to the participating study site with a VLU, DFU and / or a PU that is suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show more than two of the NERDS signs of infection. 2. Subject is 18 years of age or older. 3. The wound is between 21 days and 6 months of age or more than 6 months of age if less than 1cm2 in area. 4. Subject agrees to complete all aspects of the study and provides written Informed Consent per IRB requirements. Exclusion Criteria: 1. Subject does not meet inclusi…
Lateral flow point of care test for the qualitative detection of bacterial protease activity in wound fluid.
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