Tegaderm Vs. Transpore for Eye Protection During Anesthesia

Not Applicable

Completed

• Conditions: Eyelid Erythema
• Interventions: Device: Transpore Eye Tape; Device: Tegaderm Eye Tape

• Registration Number: NCT04918290
• Lead Sponsor: Tufts Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-08
• Study Start: 2021-06-11
• Primary Completion: 2024-04-17
• Study Completion: 2024-05-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transpore Right	Transpore Eye Tape	After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye.
Tegaderm Left	Tegaderm Eye Tape	After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye

Primary Outcome Measures

Name	Time	Method
The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore	Immediately after tape removal	Degree of erythema seen in the photo taken of the eyelid immediately after the tape is removed after surgery

Secondary Outcome Measures

Name	Time	Method
Edema	Immediately after tape removal	Edema seen after eye tape removal
Epidermal Change	Immediately after tape removal	Any epidermal changes seen on the eyelid

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States