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
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.
Description
Determining if a large, traumatic extremity wound is ready for successful delayed closure remains a challenge, as approximately 23%-25% of these wounds fail to heal after delayed closure is attempted, even when treated with aggressive surgical interventions, including debridement every 2-3 days. This pilot trial uses WounDx™, a device that aids clinicians in identifying extremity wounds that are likely to heal after surgical closure. The device is a Clinical Decision Support Tool (CDST) and consists of two main components: an immunoassay to obtain the expression of inflammatory biomarkers and,…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceClinical Decision Support Tool
WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
- ProcedureStandard 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 HospitalBirmingham, Alabama
- Emory University / Grady Memorial HospitalAtlanta, Georgia
- Indiana University Health University HospitalIndianapolis, Indiana
- Duke University HospitalDurham, North Carolina
- Brooke Army Medical CenterFort Sam Houston, Texas