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.
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
Insulin Dependent Diabetes
Peripheral Vascular Disease
Connective Tissue Disorders
Preexisting immunosuppressive conditions or immunosuppression therapy
Parallel
Clinical Decision Support Tool
DeviceWounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
Standard of Care (SOC)
Procedure/SurgeryThe standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement
Number of Patients from Each Site that Completes the Exploratory Outcome Measures
The primary outcome will be a report detailing the total number of patients from each site who have successfully completed all exploratory outcome measures. It is expected that a minimum of 3 patients from each site will complete required exploratory outcome measures.
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
Duke University
Collaborator
University of Alabama at Birmingham
Collaborator
Brooke Army Medical Center
Collaborator
Grady Memorial Hospital
Collaborator
Indiana University Health
Collaborator
Uniformed Services University of the Health Sciences
Collaborator
Emory University
Collaborator
