The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- AHS Cancer Control Alberta
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Clinical course of pressure injury over time
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
IES Device + Standard of Care
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.
Intervention: IES System (Device)
IES Device + Standard of Care
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.
Intervention: Standard of Care Therapy (Other)
Standard of Care
Standard of care treatment for pressure injuries is turning the patient every two hours.
Intervention: Standard of Care Therapy (Other)
Outcomes
Primary Outcomes
Clinical course of pressure injury over time
Time Frame: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
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.
Secondary Outcomes
- Cox Regression Analysis(Final analysis will be performed at end of study (expected completion 2 years))
- Relative Risk(Final analysis will be performed at end of study (expected completion 2 years))
- Clinical course of pressure injury in subgroups(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(Final analysis will be performed at end of study (expected completion 2 years))
- Description of adverse events related to IES(Final analysis will be performed at end of study (expected completion 2 years))
- Observed Counts of Pressure Injuries(Final analysis will be performed at end of study (expected completion 2 years))
- Onset Time(Final analysis will be performed at end of study (expected completion 2 years))
- Duration of Inpatient Stay(Final analysis will be performed at end of study (expected completion 2 years))