Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435143
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-09
Brief Title:
Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Validation and Usability Study of Intermittent Electrical Simulation Prelivia IES in the Management of Pressure Injuries Stage 1 and Stage 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IESPI
Brief Summary:
The focus of this study will be early stage pressure ulcers which can quickly progress to stage 3 4 or deep tissue injury The proposed study explores the feasibility of intermittent electrical stimulation IESPrelivia a novel non-invasive technology in the management of stage 1 and 2 pressure ulcers
Detailed Description:
Pressure ulcers also known as pressure injuries or bedsores constitute a major morbidity in critically ill patients due to immobilization deranged tissue perfusion and poor nutrition It is estimated that the prevalence of pressure injuries is 22 to 239 percent or higher depending on the hospital environment significantly contributing to nosocomial risk and healthcare costs
Particularly they are one of the most common complications among people with limited mobility is increased pressure on certain areas of the body causing reduced blood flow and damage to the skin
There has been extensive research that shows electrical stimulation can be useful in pressure ulcer treatment Arora et al 2020 5 Electrical stimulation is provided by an electrical current which can be applied in many ways
The study intervention applies Intermittent Electrical Stimulation IES to the affected area through surface electrodes The device invokes muscle contractions for 10 seconds every 10 minutes emulating the subconscious adjustments performed by able- bodied individuals in response to discomfort when seated or lying down Animal studies demonstrate that IES reduces internal pressure at bone-muscle interfaces the hypothesized mechanism for injury development increases tissue oxygenation in surrounding areas and reduces or eliminates deep tissue injury in muscles subjected to prolonged loading Appendix A 6 L Solis et al 2008 7 Clinical studies support the safety feasibility and general acceptability of gluteal IES in human participants Appendix B Ahmetovic et al 2015 8 Kane et al 2017 9 This technology has been studied and has shown with strong evidence the capacity of IES to prevent sacral and ischial pressure injuries
Prelivia uses RHTs patented Intermittent Electrical Stimulation IES technology which counteracts damaging tissue compression and increases blood flow to parts of the body that are at risk Prelivia acts by mimicking the physiological micro-contractions that normally occur in mobile individuals when they fidget or shift their weight Prelivia works by restoring subconscious muscle contractions and movements or a fidgeting movement that able-bodied individuals are able do These muscle contractions increase tissue perfusion - the process in which metabolic waste is removed and fresh blood oxygen and nutrients are brought into the tissue The target musclessuch as the glutei maximi are electrically stimulated for 10 seconds every 10 minutes to restore adequate tissue perfusion to the surrounding tissue
The system consists of a battery-powered stimulator Prelivia Stimulator and disposable hydrogel electrodes Prelivias streamlined design simple application and low cost make it the ideal addition to existing standard of care procedures
Prelivia is the only device on the market that addresses poor circulation and low oxygenation in compressed areas Current pressure injury preventative interventions rely on either temporarily relieving pressure nurses turn patients every 2 hrs creams or redistributing pressure specialized mattresses cushions etc However neither of these interventions restore blood circulation tissue oxygenation or tissue perfusion
Primary objective To evaluate users interaction with the device safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital up to 30 days until patient death or discharge whatever comes first
Secondary objective Compare the status and healing time of stage 1 and 2 pressure injuries matched with the historic controls via retrospective data review Historic controls will involve consideration of various factors
Patients with documented stage 1 and 2 pressure injuries matched according to the age range gender location of pressure injuryies Body mass Index and comorbidities
Data will be requested from the Providence Healthcare Integrated Health informatics Datalab
Exploratory objective Develop high level health economic model for pressure injury cost savings
Particularly they are one of the most common complications among people with limited mobility is increased pressure on certain areas of the body causing reduced blood flow and damage to the skin
There has been extensive research that shows electrical stimulation can be useful in pressure ulcer treatment Arora et al 2020 5 Electrical stimulation is provided by an electrical current which can be applied in many ways
The study intervention applies Intermittent Electrical Stimulation IES to the affected area through surface electrodes The device invokes muscle contractions for 10 seconds every 10 minutes emulating the subconscious adjustments performed by able- bodied individuals in response to discomfort when seated or lying down Animal studies demonstrate that IES reduces internal pressure at bone-muscle interfaces the hypothesized mechanism for injury development increases tissue oxygenation in surrounding areas and reduces or eliminates deep tissue injury in muscles subjected to prolonged loading Appendix A 6 L Solis et al 2008 7 Clinical studies support the safety feasibility and general acceptability of gluteal IES in human participants Appendix B Ahmetovic et al 2015 8 Kane et al 2017 9 This technology has been studied and has shown with strong evidence the capacity of IES to prevent sacral and ischial pressure injuries
Prelivia uses RHTs patented Intermittent Electrical Stimulation IES technology which counteracts damaging tissue compression and increases blood flow to parts of the body that are at risk Prelivia acts by mimicking the physiological micro-contractions that normally occur in mobile individuals when they fidget or shift their weight Prelivia works by restoring subconscious muscle contractions and movements or a fidgeting movement that able-bodied individuals are able do These muscle contractions increase tissue perfusion - the process in which metabolic waste is removed and fresh blood oxygen and nutrients are brought into the tissue The target musclessuch as the glutei maximi are electrically stimulated for 10 seconds every 10 minutes to restore adequate tissue perfusion to the surrounding tissue
The system consists of a battery-powered stimulator Prelivia Stimulator and disposable hydrogel electrodes Prelivias streamlined design simple application and low cost make it the ideal addition to existing standard of care procedures
Prelivia is the only device on the market that addresses poor circulation and low oxygenation in compressed areas Current pressure injury preventative interventions rely on either temporarily relieving pressure nurses turn patients every 2 hrs creams or redistributing pressure specialized mattresses cushions etc However neither of these interventions restore blood circulation tissue oxygenation or tissue perfusion
Primary objective To evaluate users interaction with the device safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital up to 30 days until patient death or discharge whatever comes first
Secondary objective Compare the status and healing time of stage 1 and 2 pressure injuries matched with the historic controls via retrospective data review Historic controls will involve consideration of various factors
Patients with documented stage 1 and 2 pressure injuries matched according to the age range gender location of pressure injuryies Body mass Index and comorbidities
Data will be requested from the Providence Healthcare Integrated Health informatics Datalab
Exploratory objective Develop high level health economic model for pressure injury cost savings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None