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Tegaderm vs. EyeGard for Eye Protection

Primary Purpose

Erythema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical tapes: TegadermTM and EyeGard®
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Erythema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TegadermTM on R eye, EyeGard® on L eye

TegadermTM on L eye, EyeGard® on R eye

Arm Description

Patients will get TegadermTM on Right eye, EyeGard® on Left eye

Patients will get TegadermTM on Left eye, EyeGard® on Right eye

Outcomes

Primary Outcome Measures

Proportion of Participants With Eyelid Erythema
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 mild erythema moderate erythema severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis.

Secondary Outcome Measures

Patient Satisfaction
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.
Rate of Corneal Abrasions
Corneal abrasion is assessed in the recovery room

Full Information

First Posted
May 25, 2018
Last Updated
August 20, 2019
Sponsor
Tufts Medical Center
Collaborators
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT03549429
Brief Title
Tegaderm vs. EyeGard for Eye Protection
Official Title
A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares TegadermTM and EyeGard® in general anesthesia.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Every patient will have each tape on each eye -EyeGard® on one eye and the TegadermTM on the other eye according to the randomization schema.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TegadermTM on R eye, EyeGard® on L eye
Arm Type
Experimental
Arm Description
Patients will get TegadermTM on Right eye, EyeGard® on Left eye
Arm Title
TegadermTM on L eye, EyeGard® on R eye
Arm Type
Experimental
Arm Description
Patients will get TegadermTM on Left eye, EyeGard® on Right eye
Intervention Type
Device
Intervention Name(s)
Medical tapes: TegadermTM and EyeGard®
Intervention Description
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
Primary Outcome Measure Information:
Title
Proportion of Participants With Eyelid Erythema
Description
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 mild erythema moderate erythema severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis.
Time Frame
Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
post-operation
Title
Rate of Corneal Abrasions
Description
Corneal abrasion is assessed in the recovery room
Time Frame
post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Drzymalski, MD
Organizational Affiliation
Tufts Medical Center Dept. of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32095992
Citation
Drzymalski DM, Ward K, Hernandez JM, Hoot J, Au SC, Yang FC, Azocar RJ. The effect of Tegaderm versus EyeGard(R) on eyelid erythema during general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):560-567. doi: 10.1007/s12630-020-01588-6. Epub 2020 Feb 13. Erratum In: Can J Anaesth. 2020 Mar 5;:
Results Reference
derived

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Tegaderm vs. EyeGard for Eye Protection

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