Tegaderm vs. Transpore for Eye Protection During Anesthesia

Study Overview
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Brief Summary
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The purpose of this study is to compare the rate of eyelid erythema after anesthesia with the use of TegadermTM vs. the Transpore®. Our null hypothesis is that the rate of erythema will be similar between the two groups given there is no evidence currently to suggest otherwise

Detailed Description
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At Tufts Medical Center, a variety of adhesive tapes are used to shut the eyes during anesthesia, including 3MTM TegadermTM and the Sharn Anesthesia Transpore®, with no preference for one or the other. While all of these products decrease the risk of corneal abrasion, none of these products have been shown to be superior to the others in terms of eyelid irritation. According to Sharn Anesthesia, The [Transpore®] adhesive is light enough to reduce damage to the outer eye (3). However, there is no scientific evidence to support this claim. All the investigators know is that the Transpore is coated with a medical grade, pressure-sensitive acrylic adhesive and that there are no phthalates, it is latex free and silicone free.

Official Title
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A Randomized Controlled Trial of Tegaderm vs. Transpore for Eye Protection During Anesthesia

Conditions
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Eyelid Erythema

Intervention / Treatment
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* Device: Tegaderm Eye Tape
* Device: Transpore Eye Tape


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old 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 less than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will perform a prospective, double-blind, randomized controlled trial. The co-investigator will ask the study subject to close his or her eyes and will take a photograph of the eyelids as a baseline assessment. Then, the co-investigator will apply the Transpore® on one eye and the TegadermTM on the other eye according to the randomization schema. The exact time of application will be documented. At the end of the surgery, the co-investigator will remove the Transpore® and TegadermTM. She will then take another photograph of the eyelids and document the time. The Cloud storage folder containing the photographs will be shared with the dermatologists who will evaluate the degree of erythema.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegaderm Left<br>After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye | Device: Tegaderm Eye Tape<br>* Eye tape to protect the eye from corneal abrasions during surgery.<br>|
| Experimental: Transpore Right<br>After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye. | Device: Transpore Eye Tape<br>* Eye tape to protect the eye from corneal abrasions during surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore | Degree of erythema seen in the photo taken of the eyelid immediately after the tape is removed after surgery | Immediately after tape removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidermal Change | Any epidermal changes seen on the eyelid | Immediately after tape removal | 
| Edema | Edema seen after eye tape removal | Immediately after tape removal |