Eyelid ErythemaNCT04918290
Tegaderm Vs. Transpore for Eye Protection During Anesthesia
A study testing Tegaderm Eye Tape and Transpore Eye Tape in people with Eyelid Erythema, run by Tufts Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eyelid Erythema
- What is being tested?
- Tegaderm Eye Tape and Transpore Eye Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Surgeries scheduled for anesthesia of any duration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of 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
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.
- Conditions
- Eyelid Erythema
- Being tested
- Tegaderm Eye Tape, Transpore Eye Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm Eye TapeDevice
Eye tape to protect the eye from corneal abrasions during surgery.
Transpore Eye TapeDevice
Eye tape to protect the eye from corneal abrasions during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Tegaderm Left | Experimental | After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye Receives: Device: Tegaderm Eye Tape |
| Transpore Right | Experimental | After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye. Receives: Device: Transpore Eye Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after tape removal
Secondary outcomes (2)
Epidermal Change
Any epidermal changes seen on the eyelid
Measured: Immediately after tape removal
Edema
Edema seen after eye tape removal
Measured: Immediately after tape removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start11 Jun 2021
- Primary completion17 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eyelid ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918290
- Sponsor's protocol ID
- 13262
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2021
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans to share the individual participant data. The individual patient records will be kept secure in an office setting.
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 3195772Zeng 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Tegaderm Vs. Transpore for Eye Protection During Anesthesia
- ClinicalTrials.gov ID
- NCT04918290
- Acronym / sponsor ID
- 13262
- Conditions
- Eyelid Erythema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tegaderm Left | Experimental | Device: Tegaderm Eye TapeAfter general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye |
| Transpore Right | Experimental | Device: Transpore Eye TapeAfter general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years old
- Surgeries scheduled for anesthesia of any duration
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tegaderm Eye TapeEye tape to protect the eye from corneal abrasions during surgery. | Device | Tegaderm Left |
| Transpore Eye TapeEye tape to protect the eye from corneal abrasions during surgery. | Device | Transpore Right |
Primary outcome
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
2 secondary outcomes
Epidermal Change
Time frame: Immediately after tape removal
Edema
Time frame: Immediately after tape removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 3195772Cucchiara 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.
- Background: PubMed 27382368Zeng 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegaderm Eye Tape and Transpore Eye Tape in people with Eyelid Erythema, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore (time frame: Immediately after tape removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918290, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.