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NOT YET RECRUITING
NCT06921707
NA

Pilot Trial for WounDx™ Clinical Decision Support Tool

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-21

Completion Date

2026-09-20

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

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.

PROCEDURE

Standard 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 Hospital

Birmingham, Alabama, United States

Emory University / Grady Memorial Hospital

Atlanta, Georgia, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Duke University Hospital

Durham, North Carolina, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States