Project Details
Description
The primary aim of this study is to compare the efficacy of transforming powder dressing (TPD) in reducing primary dressing changes in the treatment of non-infected Stage 2 and 3 Pressure Injuries (PrIs) over a 12-week period versus standard of care therapies recommended within the 2019 Guidelines (SOC). The secondary aims include comparing TPD’s impact on (1) wound healing trajectories, incidence and time to heal; (2) safety in the form of adverse events and frequency of complications including secondary infections, escalations in the stage of PrIs, hospitalizations and surgical interventions; (3) subject satisfaction, pain and quality of life; (4) ease of use and clinician satisfaction; and (5) resource utilization in the form of labor time and material costs, versus SOC. Data will be stratified based on the stage of PrIs. The impact on the primary and secondary endpoints of potentially confounding variables will also be assessed including subject demographics, mobility, wound characteristics, type of SOC device, pressure relief and nutrition supplementation practices. This information will provide preliminary data to improve our understanding of the use of TPD in clinical practice and inform recommendations for further use in clinical and field applications.
Status | Active |
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Effective start/end date | 9/1/21 → 8/31/23 |
Funding
- ULURU Inc. (CDMRP-1-008//W81XWH2110616)
- U.S. Army Medical Research and Materiel Command (CDMRP-1-008//W81XWH2110616)
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