Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

Study Overview
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Brief Summary
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The proposed study assesses the superiority of IES supplementation to the standard of care alone (offloading pressure every two hours) in improving the prevention and treatment of sacral and ischial pressure injuries.

Official Title
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The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

Conditions
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Pressure Injury

Intervention / Treatment
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* Device: IES System
* Other: Standard of Care Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Modified Braden Scale score of 14 or less. The Modified Braden Scale score is calculated as follows: Braden Scale score (Ranges from 6 to 23) 1 for Low Serum Albumin 1 for Type II Diabetes Anticipated length of stay of at least 4 days BMI < 35 Participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf. Exclusion Criteria: Existing pressure injuries above Stage II and injuries classified as DTI or unstageable Neuromuscular blocking drugs & myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction Rhabdomyolysis Use of a Pacemaker Skin breakdown over the gluteal regions that would preclude the use of surface electrodes.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IES Device + Standard of Care<br>Intermittent electrical stimulation system. Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10s every 10 minutes. The intervention is administered 24/7 and added to the standard of care management. Standard of care is defined as turning the patient every two hours. | Device: IES System<br>* The IES system is composed of a stimulator and self-adhesive surface gel electrodes.<br>Other: Standard of Care Therapy<br>* Standard institutional practices for treating pressure injury.<br>|
| Active Comparator: Standard of Care<br>Standard of care treatment for pressure injuries is turning the patient every two hours. | Other: Standard of Care Therapy<br>* Standard institutional practices for treating pressure injury.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical course of pressure injury over time | Chauhan Weighted Trajectory Analysis (CWTA) will be used to compare the morbidity associated with sacral and ischial pressure injuries through time. A one-sided Chauhan logrank test at a significance of 0.05 will be used to assess for superiority of the experimental arm over the control arm. | Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical course of pressure injury in subgroups | Chauhan Weighted Trajectory Analysis (CWTA) will be used to compare the morbidity associated with sacral and ischial pressure injuries through time. A one-sided Chauhan logrank test at a significance of 0.05 will be used to assess superiority. | Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days. | 
| Kaplan-Meier Time-to-Event Analysis | A Kaplan Meier Curve and logrank Test (one-sided significance at p < 0.05) will be used to evaluate a difference in sacral and ischial pressure injury time-to-event morbidity between groups. An event is defined as the development of any stage/class of pressure ulcer. | Final analysis will be performed at end of study (expected completion 2 years) | 
| Cox Regression Analysis | Cox-regression analysis will be used to determine whether the implementation of the IES device is associated with a significant difference in sacral and ischial pressure injury time-to-event occurrence between treatment groups. | Final analysis will be performed at end of study (expected completion 2 years) | 
| Observed Counts of Pressure Injuries | Descriptive statistics and Chi-square testing will be used to compare in incidence rates and proportion between the treatment groups for sacral and ischial pressure injuries classified as Stage I-IV or Unstageable | Final analysis will be performed at end of study (expected completion 2 years) | 
| Onset Time | Descriptive statistics will be used to report the central tendency and spread of the onset time of a sacral and ischial pressure injury for both treatment groups and for injuries classified as Stage I-IV or Unstageable | Final analysis will be performed at end of study (expected completion 2 years) | 
| Relative Risk | Relative risk of sacral and ischial pressure injuries will be compared between treatment groups using a 2x2 contingency table with a 95% confidence interval. | Final analysis will be performed at end of study (expected completion 2 years) | 
| Duration of Inpatient Stay | Descriptive statistics will be used to report the central tendency and spread of the duration of inpatient stay for both treatment groups | Final analysis will be performed at end of study (expected completion 2 years) | 
| Description of adverse events related to IES | We will report frequency and severity of skin changes underlying the electrodes, categorized as i) transient erythema after electrode removal, ii) non-transient skin changes after electrode removal, iii) skin breakdown under electrode. | Final analysis will be performed at end of study (expected completion 2 years) |