SC2i-WounDx-001-WounDx Pilot Trial: Feasibility of WounDx in Helping Clinicians Identify Wounds Ready for Surgical Closure

What this Trial Is About

Researchers are studying the use of the WounDx medical device in hospital settings to help surgeons decide when to close large, traumatic wounds on the arms or legs. This device is still experimental and not approved by the FDA. The study aims to test if WounDx can assist clinicians in identifying wounds likely to heal well after delayed surgical closure, which remains a challenge as many such wounds fail to heal properly despite treatment. The pilot trial will help plan a larger, more definitive study in the future. Participants will receive either standard wound care or standard care plus the WounDx device report. Standard care includes wound cleaning, Negative Pressure Wound Therapy (NPWT), and surgical removal of damaged tissue every 2-3 days. The WounDx device uses biomarker tests from wound fluid along with clinical data to generate a report for surgeons about whether a wound is ready to close within 48-72 hours after the last surgery. The trial will enroll adults aged 18 to 65 with traumatic wounds of at least 75cm² treated with NPWT and delayed closure methods like skin grafts or flaps. During the study, participants will be monitored through wound fluid sampling and clinical evaluations to collect data for the WounDx device. Researchers will track how many patients complete the exploratory outcome measures over one year. The study will assess the feasibility of using WounDx in clinical practice, including recruitment, randomization, treatment, and data collection. Safety and wound healing outcomes will be observed, with participation lasting through the wound treatment and follow-up periods.

Pilot Trial for WounDx™ Clinical Decision Support Tool