The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

AHS Cancer Control Alberta1 site in 1 country4 target enrollmentFebruary 26, 2021

ConditionsPressure Injury

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pressure Injury
Sponsor: AHS Cancer Control Alberta
Enrollment: 4
Locations: 1
Primary Endpoint: Clinical course of pressure injury over time
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 26, 2021

End Date

March 14, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AHS Cancer Control Alberta

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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

•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.

Outcomes

Primary Outcomes

Clinical course of pressure injury over time

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

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.

Secondary Outcomes

Cox Regression Analysis(Final analysis will be performed at end of study (expected completion 2 years))
Relative Risk(Final analysis will be performed at end of study (expected completion 2 years))
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))
Description of adverse events related to IES(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))
Duration of Inpatient Stay(Final analysis will be performed at end of study (expected completion 2 years))