Tegaderm Vs. Transpore for Eye Protection During Anesthesia

A Randomized Controlled Trial of Tegaderm Vs. Transpore for Eye Protection During Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Eyelid Erythema
• Intervention / Treatment: Device: Tegaderm Eye Tape; Device: Transpore Eye Tape

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegaderm Left; 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; Eye tape to protect the eye from corneal abrasions during surgery.
Experimental: Transpore Right; 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; Eye tape to protect the eye from corneal abrasions during surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts Medical Center

Publications and helpful links

General Publications

• Cucchiara RF, Black S. Corneal abrasion during anesthesia and surgery. Anesthesiology. 1988 Dec;69(6):978-9. doi: 10.1097/00000542-198812000-00034. No abstract available.
• Zeng LA, Lie SA, Chong SY. Comparison of Medical Adhesive Tapes in Patients at Risk of Facial Skin Trauma under Anesthesia. Anesthesiol Res Pract. 2016;2016:4878246. doi: 10.1155/2016/4878246. Epub 2016 Jun 12.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): April 17, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Erythema
• Other Study ID Numbers: 13262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share the individual participant data. The individual patient records will be kept secure in an office setting.

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