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
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