Pilot Trial for WounDx™ Clinical Decision Support Tool
Recruiting
N/A
Interventional Study
Wounds
Wounds and Injuries
Extremity Injury
Traumatic Wounds and Injuries
Amputation, Traumatic/Surgery
Amputation, Wound
Open Fracture Wounds
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 40 (estimated)
- Sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine · Other
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About This Trial
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 fina…
Trial Locations
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Eligibility Criteria
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 Vas…
Contacts