Evidence map›Paper›PMID 38730383›Full record

ArticleTrials2024

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 and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05085288 (The PROTECT 2 Study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05085288 nasuspendednot on this map

The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial

TypeinterventionalSponsorThe Cleveland ClinicRan2022 to 2026Enrolled1,100ConditionsStage 1 Pressure Ulcer, Stage 2 Pressure UlcerArmsIntermittent electrical stimulation system (IES) treatment and turning patient every two hours, Turning population every two hours
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Chase DonaldsonDepartment of Intensive Care and Resuscitation, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA. donaldc@ccf.org.ORCID http://orcid.org/0000-0003-0274-6159
Marcelo Gama de AbreuDepartment of Intensive Care and Resuscitation, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Edward J MaschaDepartment of Quantitative Health Sciences and Outcomes Research, Lerner Research Institute; Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
James RowbottomDepartment of Intensive Care and Resuscitation, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Eric HarvesterDepartment of Intensive Care and Resuscitation, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Ashish KhannaDepartment of Anesthesiology, Section On Critical Care Medicine, Wake Forest University School of Medicine, Atrium Health Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC, 27157, USA.
Tanmay SuraDepartment of Anesthesiology, 100 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Daniel I SesslerOutcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Fabio Rodriguez PatarroyoOutcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Alper GulluogluOutcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Paul ZajicDepartment of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerpl, 5, Graz, 8036, Austria.
Utkarsh ChauhanUniversity of Alberta Medical School, 1-002 Katz Group Centre for Pharmacy and Health Research, Edmonton, AB, T6G 2E1, Canada.
Hani EssberDepartment of Anaesthesiology and Intensive Care Medicine, Medical University of Graz, Auenbruggerpl, 5, Graz, 8036, Austria.
Andrea KurzDepartments of General Anesthesiology and Outcomes Research Consortium, Department of Anesthesiology, Hospital Based Care Institute, Cleveland Clinic , 9500 Euclid Avenue, Cleveland, OH, 44195, USA.

Funding

Rehabtronics, INC RHTX2112CD
6 · The paper itself

Abstract

backgroundPressure 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.

methodsThe 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 registrationClinicalTrials.gov NCT05085288 Registered October 20, 2021.

Indexed as

Electric Stimulation TherapyMulticenter Studies as TopicPressure UlcerRandomized Controlled Trials as TopicHumansTime FactorsTreatment OutcomeWound HealingElectric stimulation therapyIntensive care unitsPressure ulcerWound healing

Identifiers

PMID38730383
PMCPMC11083768

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.