Pilot Trial for WounDx™ Clinical Decision Support Tool

The purpose of this research is to evaluate the overall use of the WounDx medical device in a clinical setting, such as a hospital. The WounDx device is experimental and not yet approved by the United States Food and Drug Administration (FDA). WounDx uses information about a patient's wound to generate a report that a surgeon may use to help determine when to close or not close the wound. The final decision to close the wound remains with the surgeon. The results from this pilot trial will inform a larger pivotal trial.

NCT Number	NCT06921707
Lead Sponsor	Henry M. Jackson Foundation for the Advancement of Military Medicine Collaborators: Duke University, University of Alabama at Birmingham, Brooke Army Medical Center, Grady Memorial Hospital, Indiana University Health, Uniformed Services University of the Health Sciences, Emory University
Conditions	Wounds, Wounds and Injuries, Extremity Injury, Traumatic Wounds and Injuries, Amputation, Traumatic/Surgery, Amputation, Wound, Open Fracture Wounds
Enrollment	40 participants
Start Date	2026-05-01
Primary Completion	2026-09-20 (estimated)
Study Completion	2026-09-20 (estimated)
Updated on ClinicalTrials.gov	2026-07-30