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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage 1 Pressure Ulcer; Stage 2 Pressure Ulcer
• Intervention / Treatment: Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours; Other: Turning population every two hours

Detailed Description

This is a two-arm, prospective randomized control trial assessing whether IES combined with the standard of care (treatment) is superior to the standard of care alone (control). The study is a parallel design, adaptive, non-blinded randomized controlled trial, and uses two-sided analysis. We plan interim analyses at each 25% of the N. Part of the early interim analyses (first and second) will involve reassessing the a priori assumptions on data distributions and variability use in sample size calculations and updating the study size needed. Treatment effect results will be shared with the Data Safety Monitoring Board (DSMB) to determine whether the study should be ended early for either futility or having demonstrated superiority of the intervention. Patients can be entered into the protocol multiple times with independent assessments of inclusion/exclusion criteria and new consent for each enrollment. At each enrollment they will be re-randomized to either experimental or control arm. For the purpose of overall survival analysis (the only endpoint with a delayed assessment of outcome), such patients will be excluded.

This trial studies adult inpatients in both ICU and non-ICU environments with either new or established stage 1 or stage 2 sacral and ischial pressure injuries. Patients with a pacemaker/AICD, rhabdomyolysis, gluteal skin breakdown, and unstable fractures at risk of displacement by IES are excluded. Patients with atrial or ventricular wires after cardiac surgery can be enrolled as long as they are not being paced or in the opinion of the treating physician are at high risk of requiring pacing.

Subjects will be assessed for pressure injury status from point of randomization to discharge, death, or a minimum of 30 days. Device utilization and data collection can stop after 14 days in a non-ICU environment or when a total of 30 days of data collection has been met. If subjects are in the ICU longer than 30 days or when the combined total of ICU and less than 14 non-ICU days is greater than 30 days, the assessment and use of the device may continue after 30 days. Following entry into the study, participants will receive either the IES device in addition to the standard of care (treatment group) or the standard of care alone (control group). The study is expected to complete accrual within 12-18 months. Participant treatment will occur for the same amount of time as pressure injury assessment occurs as described above.

• Study Type: Interventional
• Enrollment (Estimated): 1100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabio Rodriguez, MD; Phone Number: 216-444-9950; Email: rodrigf3@ccf.org
• Study Contact Backup: Name: Fabio Rodriguez; Phone Number: 216-444-9950; Email: rodrigf3@ccf.org

Study Locations

• Austria
  • Graz, Austria, A-8010
    • Recruiting
    • Univeristy of Graz
• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27109
      • Recruiting
      • Wake Forest Unverisity
      • Principal Investigator: Ashish Khanna, MD
      • Contact: Lynne Harris; Phone Number: 336-306-0778; Email: lcharris@wakehealth.edu
      • Contact: Ashish Khanna, MD; Email: ashish9805@icloud.com
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Roberta Johnson; Phone Number: 216-444-9950; Email: johnsor13@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Either new or established stage 1 or 2 sacral or ischial pressure ulcer in the ICU or non-ICU environments.
• Participants capable of giving informed consent, or if propitiate, participants having an acceptable individual capable of giving consent on the participant's behalf.

Exclusion Criteria:

• Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction.
• Rhabdomyolysis
• Presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker.
• Skin breakdown or malignant skin involvement over the gluteal regions that would preclude the use of surface electrodes
• BMI > 40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intermittent electrical stimulation system (IES) treatment Group; Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes.	Device: Intermittent electrical stimulation system (IES) treatment and turning patient every two hours; The investigators propose to assess whether addition of the IES system and the use of standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries by decreasing progression of stage 1 and stage 2 ulcers or facilitates their healing compared to standard wound care in an inpatient critical care population.
Active Comparator: Standard of care Group; Standard inpatient nursing practice for wound care, wound care prevention, and any other wound care or plastic surgery treatments deemed appropriate as per usual care.	Other: Turning population every two hours; The investigators propose to assess whether current standard of care wound care and wound prevention reduces the morbidity of sacral and ischial pressure injuries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of adding the IES System to standard of care	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.	24 hours of admission to the ICU or non-ICU hospital service
Compare using the IES oppose to only standard care	Investigators will assess time to resolution of the ulcer	24 hours of admission to the ICU or non-ICU hospital service

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare IES to standard care	Time to resolution of ulcer	24 hours of admission to the ICU or non-ICU hospital service
Evaluate treatment effect heterogeneity across levels of the following patient factors	A variety of patient factors will be evaluated for treatment effect heterogeneity	24 hours of admission to the ICU or non-ICU hospital service until discharged

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Chase Donaldson, MD, The Cleveland Clinic; Study Chair: Andrea Kurz, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Wounds and Injuries; Skin Ulcer; Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: 21-1009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No