Pilot Trial for WounDx™ Clinical Decision Support Tool
SC2i-WounDx-001-WounDx™ Pilot Trial: Proof of Concept Feasibility for the Clinical Operations of WounDx™ in Aiding Clinicians Identify Wounds That Are Ready For Surgical Closure
Henry M. Jackson Foundation for the Advancement of Military Medicine
40 participants
Mar 21, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- Insulin Dependent Diabetes
- Peripheral Vascular Disease
- Connective Tissue Disorders
- Preexisting immunosuppressive conditions or immunosuppression therapy
- Pregnancy
- Prisoners
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Interventions
WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06921707