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Pilot Trial for WounDx™ Clinical Decision Support Tool

RecruitingNAAges 18 Years - 65 YearsAllHenry M. Jackson Foundation for the Advancement o…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Clinical Decision Support Tool
  • Standard of Care (SOC)
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Where

5 sites
University of Alabama - Birmingham Hospital
Birmingham, United States
Emory University / Grady Memorial Hospital
Atlanta, United States
Indiana University Health University Hospital
Indianapolis, United States
Duke University Hospital
Durham, United States
Brooke Army Medical Center
Fort Sam Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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