Status:
RECRUITING
Performance of WOUNDCHEK Bacterial Status
Lead Sponsor:
Woundchek Laboratories BV
Collaborating Sponsors:
Northwell Health
Conditions:
Wound Heal
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
- Subject is 18 years of age or older.
- The wound is between 21 days and 6 months of age or more than 6 months of age if less than 1cm2 in area.
- Subject agrees to complete all aspects of the study and provides written Informed Consent per IRB requirements.
Exclusion
- Subject does not meet inclusion criteria.
- Target wound contains a malignancy.
- Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface.
- Subject is confirmed to be positive for HIV or hepatitis
- .
- Subject is unable or unwilling to provide informed consent.
- A designated wound area may only be enrolled once in the study. For example, if an enrolled wound heals to complete closure and then re-opens, it cannot be re-enrolled in this study.
Key Trial Info
Start Date :
June 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06501105
Start Date
June 18 2024
End Date
December 1 2024
Last Update
July 15 2024
Active Locations (1)
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1
Northwell Health Comprehensive Wound Healing & Hyperbaric Center
Lake Success, New York, United States, 11042