Verify the Performance of the Neutral Electrode (NE) Adhesives

Medline Industries

Status: Completed

Conditions: Adhesion of the Neutral Electrode 21pad

Treatments: Device: Medline NE Grounding Pad

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05376787

F2P27778

Details and patient eligibility

About

The purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard IEC 60601-2-2 section 201.15.101.7. A neutral electrode is placed on the body of patients undergoing surgery that involves the use of electric current, to protect them from the harmful effects of the electricity.

Full description

Two neutral electrodes will be applied to the front of your thighs. The study staff will set up and attach a pulley system to the neutral electrodes. The purpose of the pulley system is to apply a force pulling the neutral electrode away from your body. The force will be applied for 10 minutes on each neutral electrode in one direction, and then for another 10 minutes in a second direction. Site staff will mark any areas of separation and the neutral electrodes will be removed.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be willing to comply with all study procedures
• Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Exclusion criteria

• The participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, sunburn, etc.) at the application sites that might be adversely affected by the application of an adhesive pad.
• The participant is pregnant or breastfeeding.

Trial design

20 participants in 1 patient group

Healthy Subjects

Description:

Participants must be willing to comply with all study procedures Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Treatment:

Device: Medline NE Grounding Pad