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OpenTrials
Completed

NCT Number: NCT04918290

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

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Key information

Conditions

Eyelid Erythema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegaderm Eye Tape

Device

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

Transpore Eye Tape

Device

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

Primary outcomes

  1. The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore

    Time frame: Immediately after tape removal

    Degree of erythema seen in the photo taken of the eyelid immediately after the tape is removed after surgery

Secondary outcomes

  1. Epidermal Change

    Time frame: Immediately after tape removal

    Any epidermal changes seen on the eyelid

  2. Edema

    Time frame: Immediately after tape removal

    Edema seen after eye tape removal

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2021
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.