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CompletedNCT04918290Updated Oct 28, 2024

Tegaderm Vs. Transpore for Eye Protection During Anesthesia

An interventional study of Tegaderm Eye Tape and Transpore Eye Tape in Eyelid Erythema, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Tufts Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Apr 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Eyelid Erythema

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03

In context

Erythema

131 studies on the registry are indexed under Erythema; 17 are open to participants now.

This study's enrollment of 165 is above the median of 50 across 114 interventional studies indexed under Erythema.

Browse Erythema studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least 18 years old
  • Surgeries scheduled for anesthesia of any duration

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
165 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Immediately after tape removal

Secondary outcomes

  1. Epidermal Change

    Any epidermal changes seen on the eyelid

    Time frame: Immediately after tape removal

  2. Edema

    Edema seen after eye tape removal

    Time frame: Immediately after tape removal

07

Study locations

1 site
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
08

References and documents

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. PubMed 3195772 ↗
  • 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. PubMed 27382368 ↗

Individual participant data

Plan to share: No — There are no plans to share the individual participant data. The individual patient records will be kept secure in an office setting.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04918290
Responsible party
Sponsor
First posted
Jun 8, 2021
Start date
Jun 11, 2021
Primary completion
Apr 17, 2024
Completion
May 15, 2024
Last update
Oct 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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