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Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation (PROTECT)

Primary Purpose

Pressure Injury

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
IES System
Standard of Care Therapy
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IES Device + Standard of Care

Standard of Care

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical course of pressure injury in subgroups
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 superiority.
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.
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.
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
Onset Time
Descriptive statistics will be used to report the central tendency and spread of the onset time of a sacral and ischial pressure injury for both treatment groups and for injuries classified as Stage I-IV or Unstageable
Relative Risk
Relative risk of sacral and ischial pressure injuries will be compared between treatment groups using a 2x2 contingency table with a 95% confidence interval.
Duration of Inpatient Stay
Descriptive statistics will be used to report the central tendency and spread of the duration of inpatient stay for both treatment groups
Description of adverse events related to IES
We will report frequency and severity of skin changes underlying the electrodes, categorized as i) transient erythema after electrode removal, ii) non-transient skin changes after electrode removal, iii) skin breakdown under electrode.

Full Information

First Posted
March 26, 2020
Last Updated
January 10, 2023
Sponsor
AHS Cancer Control Alberta
Collaborators
Rehabtronics
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1. Study Identification

Unique Protocol Identification Number
NCT04328246
Brief Title
Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Acronym
PROTECT
Official Title
The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was not feasible at site.
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
March 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Rehabtronics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IES Device + Standard of Care
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care treatment for pressure injuries is turning the patient every two hours.
Intervention Type
Device
Intervention Name(s)
IES System
Intervention Description
The IES system is composed of a stimulator and self-adhesive surface gel electrodes.
Intervention Type
Other
Intervention Name(s)
Standard of Care Therapy
Intervention Description
Standard institutional practices for treating pressure injury.
Primary Outcome Measure Information:
Title
Clinical course of pressure injury over time
Description
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 Outcome Measure Information:
Title
Clinical course of pressure injury in subgroups
Description
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 superiority.
Time Frame
Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Title
Kaplan-Meier Time-to-Event Analysis
Description
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)
Title
Cox Regression Analysis
Description
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)
Title
Observed Counts of Pressure Injuries
Description
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
Time Frame
Final analysis will be performed at end of study (expected completion 2 years)
Title
Onset Time
Description
Descriptive statistics will be used to report the central tendency and spread of the onset time of a sacral and ischial pressure injury for both treatment groups and for injuries classified as Stage I-IV or Unstageable
Time Frame
Final analysis will be performed at end of study (expected completion 2 years)
Title
Relative Risk
Description
Relative risk of sacral and ischial pressure injuries will be compared between treatment groups using a 2x2 contingency table with a 95% confidence interval.
Time Frame
Final analysis will be performed at end of study (expected completion 2 years)
Title
Duration of Inpatient Stay
Description
Descriptive statistics will be used to report the central tendency and spread of the duration of inpatient stay for both treatment groups
Time Frame
Final analysis will be performed at end of study (expected completion 2 years)
Title
Description of adverse events related to IES
Description
We will report frequency and severity of skin changes underlying the electrodes, categorized as i) transient erythema after electrode removal, ii) non-transient skin changes after electrode removal, iii) skin breakdown under electrode.
Time Frame
Final analysis will be performed at end of study (expected completion 2 years)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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 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. 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.
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

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Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

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