Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

Phase 3TerminatedNCT04328246

AHS Cancer Control Alberta4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pressure Injury

Interventions

IES SystemDEVICE

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

Standard of Care TherapyOTHER

Standard institutional practices for treating pressure injury.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Clinical course of pressure injury in subgroups

Time frame: 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

A Kaplan Meier Curve and logrank Test (one-sided significance at p \< 0.05) will be used to evaluate a difference in sacral and ischial pressure injury time-to-event morbidity between groups. An "event" is defined as the development of any stage/class of pressure ulcer.

Time frame: Final analysis will be performed at end of study (expected completion 2 years)

Cox Regression Analysis

Cox-regression analysis will be used to determine whether the implementation of the IES device is associated with a significant difference in sacral and ischial pressure injury time-to-event occurrence between treatment groups.

Time frame: Final analysis will be performed at end of study (expected completion 2 years)

Observed Counts of Pressure Injuries

Descriptive statistics and Chi-square testing will be used to compare in incidence rates and proportion between the treatment groups for sacral and ischial pressure injuries classified as Stage I-IV or Unstageable

Data from ClinicalTrials.gov

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