Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation (PROTECT)

AHS Cancer Control Alberta

Status and phase: Terminated; Phase 3

Conditions: Pressure Injury

Treatments: Device: IES System; Other: Standard of Care Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04328246

IIT-0018

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

IES Device + Standard of Care

Experimental group

Description:

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.

Treatment:

Other: Standard of Care Therapy

Device: IES System

Standard of Care

Active Comparator group

Description:

Standard of care treatment for pressure injuries is turning the patient every two hours.

Treatment:

Other: Standard of Care Therapy