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Tegaderm vs. Transpore for Eye Protection During Anesthesia

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ClinicalTrials.gov Identifier: NCT04918290
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Eyelid Erythema Device: Tegaderm Eye Tape Device: Transpore Eye Tape Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial of Tegaderm vs. Transpore for Eye Protection During Anesthesia
Actual Study Start Date : June 11, 2021
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : February 15, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04918290


Contacts
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Contact: Dan Drzymalski, MD 617-913-8168 ddrzymalski@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Dan Drzymalski, MD         
Sponsors and Collaborators
Tufts Medical Center
More Information
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Publications:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04918290    
Other Study ID Numbers: 13262
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share the individual participant data. The individual patient records will be kept secure in an office setting.

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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
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations