Tegaderm vs. Transpore for Eye Protection During Anesthesia
Primary Purpose
Eyelid Erythema
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tegaderm Eye Tape
Transpore Eye Tape
Sponsored by
About this trial
This is an interventional other trial for Eyelid Erythema
Eligibility 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
Sites / Locations
- Tufts Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tegaderm Left
Transpore Right
Arm Description
After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye
After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Epidermal Change
Any epidermal changes seen on the eyelid
Edema
Edema seen after eye tape removal
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04918290
Brief Title
Tegaderm vs. Transpore for Eye Protection During Anesthesia
Official Title
A Randomized Controlled Trial of Tegaderm vs. Transpore for Eye Protection During Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Erythema
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tegaderm Left
Arm Type
Experimental
Arm Description
After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye
Arm Title
Transpore Right
Arm Type
Experimental
Arm Description
After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye.
Intervention Type
Device
Intervention Name(s)
Tegaderm Eye Tape
Intervention Description
Eye tape to protect the eye from corneal abrasions during surgery.
Intervention Type
Device
Intervention Name(s)
Transpore Eye Tape
Intervention Description
Eye tape to protect the eye from corneal abrasions during surgery.
Primary Outcome Measure Information:
Title
The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore
Description
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 Outcome Measure Information:
Title
Epidermal Change
Description
Any epidermal changes seen on the eyelid
Time Frame
Immediately after tape removal
Title
Edema
Description
Edema seen after eye tape removal
Time Frame
Immediately after tape removal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Drzymalski, MD
Phone
617-913-8168
Email
ddrzymalski@tuftsmedicalcenter.org
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Drzymalski, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share the individual participant data. The individual patient records will be kept secure in an office setting.
Citations:
PubMed Identifier
3195772
Citation
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.
Results Reference
background
PubMed Identifier
27382368
Citation
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.
Results Reference
background
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Tegaderm vs. Transpore for Eye Protection During Anesthesia
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