Verify the Performance of the Neutral Electrode (NE) Adhesives

The Purpose of This Study is to Verify the Performance of the Neutral Electrode (NE) Adhesives in Accordance With the Testing Specified in IEC 60601-2-2:2017, Section 201.15.101.7, Pull Test.

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.

Study Overview

• Status: Completed
• Conditions: Adhesion of the Neutral Electrode 21pad
• Intervention / Treatment: Device: Medline NE Grounding Pad

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Damascus, Maryland, United States, 20872
      • F2 Labs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Study population will consist of at least 10 males and 10 females. Participants must be healthy and of at least 18 years of age. Participants must also fit inclusion and exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Subjects; 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.	Device: Medline NE Grounding Pad; Split Universal Grounding Pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation	To determine the percentage of adhesion separation by only measuring test results that had no more than 5% of the NE adhesive area separated. At Point A where the NE connects to the pad, connect a cord to pull on the cable. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad and in a direction away from the center of the pad, with 10 to 11N (1.02 to 1.12kg) of force in the direction along the minor dimension of the pad. Set the height of the pulley so that the direction of pull shall be approximately co-planer with the plane of the connection point of the NE. The pull shall be performed by a cord connected to the NE at the cable connection point. See Figure 2 for the pull set up. The weights provide the required pull force. Start timer. At 10 mins, change direction of pull to y direction by rotating the pulley system 90 degrees as shown in Figure 2 - apply 10 to 11 N force at Point A in direction of y ray which is in a plane parallel to the pad. Start timer. At 10 mins	Up to 20 minutes - (10 minutes w. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad & At 10 mins, change direction of pull to y direction)

Collaborators and Investigators

• Sponsor: Medline Industries
• Collaborators: F2 Labs

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2022
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): June 10, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: F2P27778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No