Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

NCT04328246 | Terminated Phase 3 DMC

• 1 other identifier: IIT-0018
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury

Outcome Measures

Primary Outcomes (1)

• Clinical course of pressure injury over time

  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.

  Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.

Secondary Outcomes (8)

• 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)

• Cox Regression Analysis

  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)

Study Arms (2)

IES Device + Standard of Care

EXPERIMENTAL

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.

Device: IES System; Other: Standard of Care Therapy

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care Therapy

Interventions

IES System DEVICE

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

IES Device + Standard of Care

Standard of Care Therapy OTHER

Standard institutional practices for treating pressure injury.

IES Device + Standard of Care; Standard of Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• for Low Serum Albumin
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Rehabtronics: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: February 26, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: January 11, 2023

Record last verified: 2020-03

Locations

CA (1)