WoundSentryÖ: An Integrated Smart Dressing for Non-Invasive, Real-Time Detection of Burn Wound Infections

Burn injuries, particularly in military settings, present significant challenges due to the high risk of infection and inflammation. Current diagnostic methods require frequent dressing removal for visual assessment, which is painful and risk secondary infections. WoundSentryÖáPatch, a smart device addresses these challenges through a non-invasive, real-time monitoring system that detects volatile organic compounds (VOCs) associated with bacterial pathogens and inflammatory biomarkers. Integrating patented nanosensors and AI algorithms, WoundSentry enables early detection of infections, allowing for prompt interventions, prioritize evacuations, and reducing the need for disruptive dressing changes.During the Phase I project (DHA SBIR W81XWH22P0132), NanoBioFab successfully developed an alpha prototype of WoundSentry, demonstrating its efficacy in detecting VOCs from pathogens commonly implicated in burn wound infections. The device achieved 97% sensitivity and 95% specificity in identifying bacterial and fungal pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans. áBuilding on these results, the Phase II effort will focus on refining the WoundSentry prototype into a flexible, user-friendly smart patch. This involves miniaturizing the sensor array and integrating it into a wound dressing capable of real-time monitoring. The sensor will provide early alerts through an integrated LED system, allowing healthcare providers to assess infection status without removing the dressing. The device will undergo rigorous in vitro and in vivo testing using a porcine burn model to validate its performance and ensure compliance with clinical and regulatory standards.In vivo testing will utilize deep partial-thickness burns in a porcine model to simulate human wound conditions, with controlled infections from pathogens such as Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. The WoundSentry device will continuously monitor VOCs emitted from the wound site, providing real-time diagnostic data that correlates with bacterial load and clinical signs of infection and/or prior to the inflammation cascade. These results will be used to refine AI algorithms for pathogen identification and early infection and inflammation detection.In parallel, NanoBioFab will engage with the FDA through the Q-Submission process, seeking feedback on the device's design, clinical protocols, and regulatory pathway. This proactive engagement will help ensure compliance with regulatory standards, positioning WoundSentry for a smooth transition to human clinical trials.After Phase II, WoundSentry will be ready for manufacturing and large-scale clinical validation and commercialization, providing a transformative solution for burn wound management in both military and civilian settings. Its dual-use application will benefit patients across healthcare environments, from battlefield injury management to routine wound care in hospitals.