Clinical trial NCT04918290: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Erythema
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore
timeFrame: Immediately after tape removal
Secondary outcomes:
measure: Epidermal Change
timeFrame: Immediately after tape removal
measure: Edema
timeFrame: Immediately after tape removal
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
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.
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.