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Donaldson, C; de, Abreu, MG; Mascha, EJ; Rowbottom, J; Harvester, E; Khanna, A; Sura, T; Sessler, DI; Patarroyo, FR; Gulluoglu, A; Zajic, P; Chauhan, U; Essber, H; Kurz, A.
Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial.
Trials. 2024; 25(1):313
Doi: 10.1186/s13063-024-08085-x
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- Co-authors Med Uni Graz
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Essber Hani Antoun
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Kurz Andrea
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Zajic Paul
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- Abstract:
- BACKGROUND: Pressure ulcers account for a substantial fraction of hospital-acquired pathology, with consequent morbidity and economic cost. Treatments are largely focused on preventing further injury, whereas interventions that facilitate healing remain limited. Intermittent electrical stimulation (IES) increases local blood flow and redistributes pressure from muscle-bone interfaces, thus potentially reducing ulcer progression and facilitating healing. METHODS: The Pressure Injury Treatment by Intermittent Electrical Stimulation (PROTECT-2) trial will be a parallel-arm multicenter randomized trial to test the hypothesis that IES combined with routine care reduces sacral and ischial pressure injury over time compared to routine care alone. We plan to enroll 548 patients across various centers. Hospitalized patients with stage 1 or stage 2 sacral or ischial pressure injuries will be randomized to IES and routine care or routine care alone. Wound stage will be followed until death, discharge, or the development of an exclusion criteria for up to 3 months. The primary endpoint will be pressure injury score measured over time. DISCUSSION: Sacral and ischial pressure injuries present a burden to hospitalized patients with both clinical and economic consequences. The PROTECT-2 trial will evaluate whether IES is an effective intervention and thus reduces progression of stage 1 and stage 2 sacral and ischial pressure injuries. TRIAL REGISTRATION: ClinicalTrials.gov NCT05085288 Registered October 20, 2021.
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Humans - administration & dosage
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Pressure Ulcer - therapy
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Electric Stimulation Therapy - methods
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Multicenter Studies as Topic - administration & dosage
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Randomized Controlled Trials as Topic - administration & dosage
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Treatment Outcome - administration & dosage
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Time Factors - administration & dosage
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Wound Healing - administration & dosage
- Find related publications in this database (Keywords)
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Pressure ulcer
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Electric stimulation therapy
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Intensive care units
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Wound healing