Tegaderm vs. EyeGard for Eye Protection

August 20, 2019 updated by: Tufts Medical Center

A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia

This study compares TegadermTM and EyeGard® in general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18
  • Surgeries scheduled for anesthesia of any duration

Exclusion Criteria:

  • Any patient that does not consent
  • Any patient who has:
  • Pre-existing eyelid erythema or other eyelid trauma
  • Eyelid piercings
  • Any surgery on the head, brain, neck, teeth, mouth, eyes or face
  • Surgery in the prone position
  • Patients <18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TegadermTM on R eye, EyeGard® on L eye
Patients will get TegadermTM on Right eye, EyeGard® on Left eye
Device: Medical tapes: TegadermTM and EyeGard®
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
Experimental: TegadermTM on L eye, EyeGard® on R eye
Patients will get TegadermTM on Left eye, EyeGard® on Right eye
Device: Medical tapes: TegadermTM and EyeGard®
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Eyelid Erythema
Time Frame: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)

The amount of erythema caused upon removal of the tape is the primary outcome of interest. Investigators will use the following 0-3 tape-associated skin index grading scale to grade eyelid erythema:

0- no erythema

  1. mild erythema
  2. moderate erythema
  3. severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis.
Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: post-operation
Patient Satisfaction will be based on one question and graded on a Likert Scale from 1-5. A score of 5 is considered better (higher satisfaction), while a 1 is considered lower. There are no subscales.
post-operation
Rate of Corneal Abrasions
Time Frame: post-operation
Corneal abrasion is assessed in the recovery room
post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

Tufts University

Investigators

  • Principal Investigator: Dan Drzymalski, MD, Tufts Medical Center Dept. of Anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

July 19, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

May 25, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

June 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12884

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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