- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328246
Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation (PROTECT)
January 10, 2023 updated by: AHS Cancer Control Alberta
The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
The IES system is composed of a stimulator and self-adhesive surface gel electrodes.
Standard institutional practices for treating pressure injury.
|
Active Comparator: Standard of Care
Standard of care treatment for pressure injuries is turning the patient every two hours.
|
Standard institutional practices for treating pressure injury.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
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.
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Cox Regression Analysis
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
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.
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Observed Counts of Pressure Injuries
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
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
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Onset Time
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
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
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Relative Risk
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
Relative risk of sacral and ischial pressure injuries will be compared between treatment groups using a 2x2 contingency table with a 95% confidence interval.
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Duration of Inpatient Stay
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
Descriptive statistics will be used to report the central tendency and spread of the duration of inpatient stay for both treatment groups
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Description of adverse events related to IES
Time Frame: Final analysis will be performed at end of study (expected completion 2 years)
|
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.
|
Final analysis will be performed at end of study (expected completion 2 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2021
Primary Completion (Actual)
March 14, 2022
Study Completion (Actual)
March 14, 2022
Study Registration Dates
First Submitted
March 26, 2020
First Submitted That Met QC Criteria
March 27, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Estimate)
January 11, 2023
Last Update Submitted That Met QC Criteria
January 10, 2023
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT-0018
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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