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

Launched by UNIVERSITY OF BRITISH COLUMBIA · May 23, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2" is looking to test a new treatment for early-stage pressure injuries (also known as pressure ulcers). These injuries can develop quickly into more serious stages if not treated properly. The study will explore a non-invasive device called Prelivia, which uses intermittent electrical stimulation to help manage these stage 1 and 2 pressure ulcers. The goal is to see how effective and user-friendly this treatment is for patients.

To be eligible for this study, participants need to be between 65 and 74 years old and have stage 1 or 2 pressure injuries located in the sacral or ischial areas, which are common spots for these types of injuries. They must also be willing to use the Prelivia device for up to 30 days. However, certain individuals cannot participate, such as those with more severe injuries (stage 3 or higher), those using specific medications that affect muscle contractions, or those with certain medical devices like pacemakers. If you join the study, you will wear the device while the researchers monitor its effects on your pressure injury. This trial is not yet recruiting participants, but it represents a promising approach to improving care for those at risk of serious pressure injuries.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: Willing and able to provide written informed consent to participate and wear Prelivia for the duration of the study but not longer than 30 days Patients with new or already established stage 1 and 2 pressure injuries BMI \<40 Pressure injury location sacral/ischial region
• • -
• Exclusion Criteria:
• • 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