Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2

NCT06435143 | Not Yet Recruiting

• 1 other identifier: H24-00304
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 (IES),Prelivia, a novel, non-invasive technology in the management of stage 1 and 2 pressure ulcers.

Conditions

Pressure Injury

Outcome Measures

Primary Outcomes (3)

• 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

  Will assess using qualitative questionnaire for both nursing staff and patient as to comfort and ease of use.

  30 days

• Compare the status and healing time of stage 1 and 2 pressure injuries matched with historical controls via retrospective data review. Historic controls will involve consideration of a various factors:

  Will perform an initial assessment of the wound (e.g. size, narrative description) and compare this pre-intervention with post-intervention after a maximum of 30 days of wear time.

  30 days

• Exploratory objective: to develop high level health economic model for pressure injury cost savings

  Measurement of cost to treat patients that developed a severe pressure ulcer compared to those that did not.

  120 days

Study Arms (1)

Patient with pressure injury stage 1 and stage 2

OTHER

Patient admitted to hospital with a confirmed stage 1 and 2 pressure injuries. Prelivia device will be applied to skin around pressure injury. Intermittent electrical stimulation will be administered for 10 seconds every 10 minutes to improve blood flow and muscle contraction to the area, simulating movement

Device: Prelivia

Interventions

Prelivia DEVICE

Pad applied to skin provide electrical stimulation for 10 seconds every 10 minutes

Also known as: Intermittent electrical stimulation

Patient with pressure injury stage 1 and stage 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• existing pressure injury above stage 2 and injuries classified as DTI or unstageable continuous neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of IES to induce muscular contraction
• electrical stimulation to induce muscular contraction
• presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker
• unstable spinal, pelvic, or hop fractures that may be displaced by a forced contraction (for sacral and ischial ulcers)
• rhabdomyolysis
• skin breakdown or malignant skin involvement over the effected regions that would preclude the use of surface electrodes
• any implantable electrostimulation device
• have pacemaker or any other implantable neurostimulation devices,
• if your pressure injury is above stage 2, or
• if you are receiving neuromuscular blocking drugs,
• if you have myasthenia gravis,
• if you have unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction or
• if you are wearing an incontinence brief and have frequently loose bowel movements

Sponsors & Collaborators

• University of British Columbia: lead
• Providence Health & Services: collaborator

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Lisa J Maks, MN

CONTACT

604-816-6523; lmaks@providencehealth.bc.ca

Melodee Dayrit, BScN

CONTACT

604-682-2344; mdayrit@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diabetes Clinical Nurse Specialist, Adjunct Professor UBC School of Nursing

Model Details: This is a feasibility study of testing Prelivia in an in-patient setting

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: November 30, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share