Pilot Trial for WounDx™ Clinical Decision Support Tool

Launched by HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE · Apr 3, 2025

Keywords

ClinConnect Summary

The WounDx Pilot Trial is a research study looking at a new medical device called WounDx. This device is designed to help doctors make decisions about closing wounds after injuries or surgeries. It works by analyzing information about a patient's wound and creating a report that provides recommendations for the surgeon. However, the final choice about whether to close the wound is always up to the surgeon. It's important to note that WounDx is still being tested and has not yet been approved by the FDA for general use.

To be eligible for this trial, participants must have a wound that is at least 75 square centimeters in size and be dealing with an extremity injury, which includes injuries to arms and legs. Some health conditions, like diabetes or certain immune disorders, may prevent someone from participating. This study is currently not recruiting participants, but once it begins, eligible individuals can expect to use the WounDx device as part of their wound care, helping doctors make informed decisions about their treatment.

Gender

ALL

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