Clinical trial NCT04328246: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Official title: The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pressure Injury
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Rehabtronics
First posted: 2020-03-31
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Anticipated length of stay of at least 4 days
3. BMI \< 35
4. 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:

1. Existing pressure injuries above Stage II and injuries classified as DTI or unstageable
2. Neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of electrical stimulation to induce muscular contraction
3. Unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction
4. Rhabdomyolysis
5. Use of a Pacemaker
6. Skin breakdown over the gluteal regions that would preclude the use of surface electrodes.

Primary outcomes:
measure: Clinical course of pressure injury over time
timeFrame: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Secondary outcomes:
measure: Clinical course of pressure injury in subgroups
timeFrame: Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
measure: Kaplan-Meier Time-to-Event Analysis
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
measure: Cox Regression Analysis
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
measure: Observed Counts of Pressure Injuries
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
measure: Onset Time
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
measure: Relative Risk
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
measure: Duration of Inpatient Stay
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
measure: Description of adverse events related to IES
timeFrame: Final analysis will be performed at end of study (expected completion 2 years)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References: