BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

Inclusion Criteria: * Age ≥ 22 years * Eligible wounds include all wound etiologies including but not limited to DFUs, VLUs, pressure injuries, and open postsurgical wounds. * Presence of at least one target wound of sufficient size to allow: Complete imaging using the investigational device, and collection of tissue biopsy samples, as required by the study protocol \- The target wound must be located in an anatomical region that permits: Full visualization, appropriate positioning for imaging, and safe and feasible biopsy sampling. * Written informed consent possible * Wound suitable for fluorescence imaging under IFU conditions with the study device and the comparator device (e.g., no excessive exudate obscuring visualization Exclusion Criteria: * The target wound cannot be completely imaged by the comparator device due to anatomical location, such as wounds that are: Too extensive to be captured within the device's field of view, positioned on curved, recessed, or otherwise inaccessible regions (e.g., deep sacral clefts, interdigital spaces). * The target wound is too small to support the required biopsy procedures without compromising participant safety or data quality. * Treatment with experimental medication within the last month * Lack of ability to consent * Contraindications for standard wound care or monitoring * Strong therapeutic anticoagulation (e.g., direct oral anticoagulants and warfarin); * Known bleeding diathesis or coagulation disorder that increas…