Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2022-03-14

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.

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Detailed Description

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Conditions

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Pressure Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IES System

Intervention Type DEVICE

The IES system is composed of a stimulator and self-adhesive surface gel electrodes.

Standard of Care Therapy

Intervention Type OTHER

Standard institutional practices for treating pressure injury.

Standard of Care

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

Group Type ACTIVE_COMPARATOR

Standard of Care Therapy

Intervention Type OTHER

Standard institutional practices for treating pressure injury.

Interventions

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IES System

The IES system is composed of a stimulator and self-adhesive surface gel electrodes.

Intervention Type DEVICE

Standard of Care Therapy

Standard institutional practices for treating pressure injury.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No