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Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328246
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Rehabtronics
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Pressure Injury Device: IES System Other: Standard of Care Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

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

Other: Standard of Care Therapy
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.
Other: Standard of Care Therapy
Standard institutional practices for treating pressure injury.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328246


Locations
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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Contact: John Mackey, MD    780-432-8221      
Principal Investigator: John Mackey, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Rehabtronics
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT04328246    
Other Study ID Numbers: IIT-0018
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020

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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
Additional relevant MeSH terms:
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Wounds and Injuries
Crush Injuries