Clinical trial NCT05085288: The PROTECT 2 Study : Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
Official title: The PROTECT 2 Study: Pressure Injury Treatment by Intermittent Electrical Stimulation: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage 1 Pressure Ulcer
Stage 2 Pressure Ulcer
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of adding the IES System to standard of care
timeFrame: 24 hours of admission to the ICU or non-ICU hospital service
measure: Compare using the IES oppose to only standard care
timeFrame: 24 hours of admission to the ICU or non-ICU hospital service
Secondary outcomes:
measure: Compare IES to standard care
timeFrame: 24 hours of admission to the ICU or non-ICU hospital service
measure: Evaluate treatment effect heterogeneity across levels of the following patient factors
timeFrame: 24 hours of admission to the ICU or non-ICU hospital service until discharged
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Unverisity
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Graz
country: Austria
facility: Univeristy of Graz
Study officials:
affiliation: The Cleveland Clinic
name: Chase Donaldson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Andrea Kurz, MD
role: STUDY_CHAIR
References: