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Tegaderm Vs. Transpore for Eye Protection During Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04918290
Enrollment
165
Registered
2021-06-08
Start date
2021-06-11
Completion date
2024-05-15
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eyelid Erythema

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.

Interventions

DEVICETegaderm Eye Tape

Eye tape to protect the eye from corneal abrasions during surgery.

DEVICETranspore Eye Tape

Eye tape to protect the eye from corneal abrasions during surgery.

Sponsors

Tufts Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. TransporeImmediately after tape removalDegree of erythema seen in the photo taken of the eyelid immediately after the tape is removed after surgery

Secondary

MeasureTime frameDescription
Epidermal ChangeImmediately after tape removalAny epidermal changes seen on the eyelid
EdemaImmediately after tape removalEdema seen after eye tape removal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026