Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

Pressure Injury Clinical Trial

— PROTECT  

Official title:

The PROTECT Study: Pressure injuRy preventiOn by inTermittent EleCtrical sTimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04328246
• Other study ID #: IIT-0018
• Status: Terminated
• Phase: Phase 3
• Start date: February 26, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: March 2020
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Rehabtronics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Secondary	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.	Patients will be assessed daily for pressure injury location and stage through treatment completion, an average of 14 days.
Secondary	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.	Final analysis will be performed at end of study (expected completion 2 years)
Secondary	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.	Final analysis will be performed at end of study (expected completion 2 years)
Secondary	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	Final analysis will be performed at end of study (expected completion 2 years)
Secondary	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	Final analysis will be performed at end of study (expected completion 2 years)
Secondary	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.	Final analysis will be performed at end of study (expected completion 2 years)
Secondary	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	Final analysis will be performed at end of study (expected completion 2 years)
Secondary	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.	Final analysis will be performed at end of study (expected completion 2 years)