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The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries.
Details
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | SUSPENDED |
| Enrolment | 1100 |
| Start date | 2022-02-08 |
| Completion | 2026-12 |
Conditions
- Stage 1 Pressure Ulcer
- Stage 2 Pressure Ulcer
Interventions
- Intermittent electrical stimulation system (IES) treatment and turning patient every two hours
- Turning population every two hours
Primary outcomes
- Efficacy of adding the IES System to standard of care — 24 hours of admission to the ICU or non-ICU hospital service
Investigators will assess the IES System to determine the efficacy of an IES system after being added to the standard of care on the primary outcome of sacral and ischial pressure injury score measured over time. - Compare using the IES oppose to only standard care — 24 hours of admission to the ICU or non-ICU hospital service
Investigators will assess time to resolution of the ulcer
Countries
United States, Austria