Status:
TERMINATED
Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Rehabtronics
Conditions:
Pressure Injury
Eligibility:
All Genders
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04328246
Start Date
February 26 2021
End Date
March 14 2022
Last Update
January 11 2023
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2