Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial
Chase Donaldson,
Marcelo Gama de Abreu,
Edward J. Mascha,
James Rowbottom,
Eric Harvester,
Ashish Khanna,
Tanmay Sura,
Daniel I. Sessler,
Fabio Rodriguez Patarroyo,
Alper Gulluoglu,
Paul Zajic,
Utkarsh Chauhan,
Hani Essber,
Andrea Kurz
Affiliations
Chase Donaldson
Department of Intensive Care and Resuscitation, Cleveland Clinic
Marcelo Gama de Abreu
Department of Intensive Care and Resuscitation, Cleveland Clinic
Edward J. Mascha
Department of Quantitative Health Sciences and Outcomes Research, Lerner Research Institute; Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute
James Rowbottom
Department of Intensive Care and Resuscitation, Cleveland Clinic
Eric Harvester
Department of Intensive Care and Resuscitation, Cleveland Clinic
Ashish Khanna
Department of Anesthesiology, Section On Critical Care Medicine, Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center
Tanmay Sura
Department of Anesthesiology
Daniel I. Sessler
Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic
Fabio Rodriguez Patarroyo
Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic
Alper Gulluoglu
Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic
Paul Zajic
Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz
Utkarsh Chauhan
University of Alberta Medical School, 1-002 Katz Group Centre for Pharmacy and Health Research
Hani Essber
Department of Anaesthesiology and Intensive Care Medicine, Medical University of Graz
Andrea Kurz
Departments of General Anesthesiology and Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic
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.
