Pilot Study of WounDx12 Clinical Decision Support Tool to Help Surgeons Identify Traumatic Extremity Wounds Ready for Surgical Closure in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the use of the WounDx medical device in a clinical hospital setting to assist surgeons in deciding when to close traumatic extremity wounds. This pilot trial aims to establish the feasibility of using WounDx, an experimental Clinical Decision Support Tool that analyzes inflammatory biomarkers and clinical data to predict wound healing success. The study focuses on adults aged 18 to 65 with large traumatic wounds treated with Negative Pressure Wound Therapy NPWT and delayed primary closure. Results from this pilot will guide a larger pivotal trial. Participants are randomly assigned to either a control group receiving standard careserial wound irrigation, NPWT, and surgical debridementor an intervention group receiving standard care plus the WounDx report to support clinical decision-making. The device provides a recommendation on wound closure timing within 48 to 72 hours after debridement, aligning with current clinical guidelines. The trial assesses the practical use of WounDx in real-world clinical operations, including recruitment, randomization, and data collection. During the study, wound effluent samples are collected to measure local and systemic inflammatory biomarkers. These data, along with clinical information, are input into the WounDx device to generate wound healing predictions. Researchers monitor the number of patients completing exploratory outcome measures over one year, evaluating the tools contribution to wound care decisions. The study spans from May 2026 to September 2026 and includes ongoing assessments to inform future larger trials.

Pilot Trial for WounDx™ Clinical Decision Support Tool