Pilot Trial for WounDx™ Clinical Decision Support Tool

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Not yet enrolling

Conditions: Open Fracture Wounds; Amputation, Wound; Extremity Injury; Wounds; Traumatic Wounds and Injuries; Wounds and Injuries; Amputation, Traumatic/Surgery

Treatments: Procedure: Standard of Care (SOC); Device: Clinical Decision Support Tool

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06921707

HU0001-23-2-0030 (Other Identifier)

Pro00117915

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard of Care (SOC)

WounDx

Experimental group

Description:

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.

Treatment:

Device: Clinical Decision Support Tool