Medline NE Pad Adhesion Testing

Sponsor

Medline Industries (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05376787

Collaborator

F2 Labs (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Adhesion of the Neutral Electrode 21pad	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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Medline NE Pad Adhesion Testing

Anticipated Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Jun 16, 2022

Anticipated Study Completion Date :

Jul 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Healthy Subjects Subjects must be 18 years old or over, willing to shave or have shaved the sites where the neutral electrodes will be placed. Subjects also must not be pregnant, breastfeeding, have skin conditions (such as eczema, sensitivities, allergies to adhesives, sunburn).	Device: Medline NE Grounding Pad Split Universal Grounding Pads

Arm

Intervention/Treatment

Healthy Subjects

Subjects must be 18 years old or over, willing to shave or have shaved the sites where the neutral electrodes will be placed. Subjects also must not be pregnant, breastfeeding, have skin conditions (such as eczema, sensitivities, allergies to adhesives, sunburn).

Device: Medline NE Grounding Pad

Split Universal Grounding Pads

Outcome Measures

Primary Outcome Measures

NE adhesive area separation [One month]
To determine the percent of adhesion pad pull test that had no more than 5% of the NE adhesive area separated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medline Industries
F2 Labs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medline Industries

ClinicalTrials.gov Identifier:

NCT05376787

Other Study ID Numbers:

F2P27778

First Posted:

May 17, 2022

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Tissue Adhesions

Study Results

No Results Posted as of May 24, 2022