An interventional study of Clinical Decision Support Tool and Standard of Care (SOC) in Wounds, Wounds and Injuries and Extremity Injury, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine · Not applicable, Interventional, and Device feasibility
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.
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, together with clinical data input, an interpretative algorithm. The purpose of the device is to identify wounds likely to proceed through normal phases of wound healing and, as a result, provide the clinician with a wound-specific prediction that an open traumatic extremity wound will heal successfully and remain closed if delayed closure is performed. The pilot trial serves as a proof of concept (POC) trial and establishes the overall feasibility of clinical operations (including recruitment, randomization, implementation of the intervention, and data collection). Trial enrollment is planned only for adults (≥18 to ≤65 years) with at least one traumatic extremity wound ≥75cm 2 , being treated with Negative Wound Pressure Therapy (NPWT), and delayed primary closure including split thickness skin grafting and rotational or free flaps. Local and systemic inflammatory biomarker expression will be assessed in wound effluent samples collected during subject treatment. These results will be input with other associated clinical data to WounDx™ to allow the device to provide a report including a recommendation on whether a specific wound should be closed within 48-72h of the previous debridement surgery, which is consistent with the current clinical practice guidelines. This pilot trial will inform the conduct of a larger, pivotal clinical trial to evaluate the safety and efficacy of WounDx™ in aiding clinicians identify traumatic extremity wounds ready for surgical closure.
Exclusion Criteria:
This is the control group that receives the standard of care of serial wound irrigation, Negative Pressure Wound Therapy, and surgical debridement with the attending clinician determining if a wound is ready to close.
Procedure: Standard of Care (SOC)
This is the intervention group that receives standard of care plus the WounDx™ report to augment the clinicians' judgment regarding the wounds readiness to close.
Device: Clinical Decision Support Tool
WounDx is a clinical decision support tool that will help augment the clinicians' judgment regarding the wounds readiness to close.
Also known as: WounDx
The standard of care consists of serial wound irrigation, negative pressure wound therapy, and surgical debridement
Also known as: Serial Wound Irrigation, Negative Wound Pressure Therapy, Surgical Debridement
Number of Patients from Each Site that Completes the Exploratory Outcome Measures
The primary outcome will be a report detailing the total number of patients from each site who have successfully completed all exploratory outcome measures. It is expected that a minimum of 3 patients from each site will complete required exploratory outcome measures.
Time frame: 1 year
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Henry M. Jackson Foundation for the Advancement of Military Medicine