Pilot Trial for WounDx™ Clinical Decision Support Tool

Conditions: Wounds, Wounds and Injuries, Extremity Injury, Traumatic Wounds and Injuries, Amputation, Traumatic/Surgery, Amputation, Wound, Open Fracture Wounds

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: NA

Enrollment: 40

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Wound surface area ≥75cm 2 * Extremity injury (including shoulder and buttock - without visceral communication) * Wound amenable to Negative Pressure Wound Therapy using 3M™ V.A.C. ® canisters without gel pack Exclusion Criteria: * Insulin Dependent Diabetes * Peripheral Vascular Disease * Connective Tissue Disorders * Preexisting immunosuppressive conditions or immunosuppression therapy * Pregnancy * Prisoners

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06921707). StuddyBuddy aggregates publicly available trial information.