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Pilot Trial for WounDx™ Clinical Decision Support Tool
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-03-21
Completion Date
2026-09-20
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Clinical Decision Support Tool
WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
Standard of Care (SOC)
The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement
Locations (5)
University of Alabama - Birmingham Hospital
Birmingham, Alabama, United States
Emory University / Grady Memorial Hospital
Atlanta, Georgia, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Duke University Hospital
Durham, North Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States