ErythemaNCT03549429
Tegaderm vs. EyeGard for Eye Protection
A study testing Medical tapes: TegadermTM and EyeGard® in people with Erythema, run by Tufts Medical Center at 1 site in United States.
Trial summary
This study compares TegadermTM and EyeGard® in general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- Medical tapes: TegadermTM and EyeGard®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18
- 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 <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia
This study compares TegadermTM and EyeGard® in general anesthesia.
Read the detailed description
Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.
- Conditions
- Erythema
- Being tested
- Medical tapes: TegadermTM and EyeGard®
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical tapes: TegadermTM and EyeGard®Device
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| TegadermTM on R eye, EyeGard® on L eye | Experimental | Patients will get TegadermTM on Right eye, EyeGard® on Left eye Receives: Device: Medical tapes: TegadermTM and EyeGard® |
| TegadermTM on L eye, EyeGard® on R eye | Experimental | Patients will get TegadermTM on Left eye, EyeGard® on Right eye Receives: Device: Medical tapes: TegadermTM and EyeGard® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Eyelid Erythema
The amount of erythema caused upon removal of the tape is the primary outcome of interest. Investigators will use the following 0-3 tape-associated skin index grading scale to grade eyelid erythema:
0- no erythema
- mild erythema
- moderate erythema
- severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis.
Measured: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
Secondary outcomes (2)
Patient Satisfaction
Patient Satisfaction will be based on one question and graded on a Likert Scale from 1-5. A score of 5 is considered better (higher satisfaction), while a 1 is considered lower. There are no subscales.
Measured: post-operation
Rate of Corneal Abrasions
Corneal abrasion is assessed in the recovery room
Measured: post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jun 2018
- Primary completion19 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Every patient will have each tape on each eye -EyeGard® on one eye and the TegadermTM on the other eye according to the randomization schema.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University
- Responsible party
- Sponsor
- Investigators
- Dan Drzymalski, MD, Principal investigator, Tufts Medical Center Dept. of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549429
- Sponsor's protocol ID
- 12884
- Status last verified
- Aug 2019
- First submitted
- 25 May 2018
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Drzymalski DM, Ward K, Hernandez JM, Hoot J, Au SC, Yang FC, Azocar RJ. The effect of Tegaderm versus EyeGard(R) on eyelid erythema during general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):560-567. doi: 10.1007/s12630-020-01588-6. Epub 2020 Feb 13.
PubMed 32095992
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia
- ClinicalTrials.gov ID
- NCT03549429
- Acronym / sponsor ID
- 12884
- Conditions
- Erythema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Tufts University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares TegadermTM and EyeGard® in general anesthesia.
Detailed description
Protective eye tape is used during anesthesia in order to prevent corneal abrasion and other eye injuries. However, there is no single accepted practice of how to protect the eyes during anesthesia, and a variety of different tapes and techniques have been adopted in different institutions. In this study, investigators will compare two tapes, TegadermTM and EyeGard® to determine if one is less likely to cause eyelid irritation in an effort to improve care for future patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Every patient will have each tape on each eye -EyeGard® on one eye and the TegadermTM on the other eye according to the randomization schema.
| Arm | Type | Receives |
|---|---|---|
| TegadermTM on R eye, EyeGard® on L eye | Experimental | Device: Medical tapes: TegadermTM and EyeGard®Patients will get TegadermTM on Right eye, EyeGard® on Left eye |
| TegadermTM on L eye, EyeGard® on R eye | Experimental | Device: Medical tapes: TegadermTM and EyeGard®Patients will get TegadermTM on Left eye, EyeGard® on Right eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- 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 |
|---|---|---|
| Medical tapes: TegadermTM and EyeGard®TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. | Device | TegadermTM on L eye, EyeGard® on R eye, TegadermTM on R eye, EyeGard® on L eye |
Primary outcome
Proportion of Participants With Eyelid Erythema
Time frame: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
The amount of erythema caused upon removal of the tape is the primary outcome of interest. Investigators will use the following 0-3 tape-associated skin index grading scale to grade eyelid erythema: 0- no erythema 1. mild erythema 2. moderate erythema 3. severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis.
2 secondary outcomes
Patient Satisfaction
Time frame: post-operation
Rate of Corneal Abrasions
Time frame: post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32095992Drzymalski DM, Ward K, Hernandez JM, Hoot J, Au SC, Yang FC, Azocar RJ. The effect of Tegaderm versus EyeGard(R) on eyelid erythema during general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):560-567. doi: 10.1007/s12630-020-01588-6. Epub 2020 Feb 13.
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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.
Dan Drzymalski, MD principal investigator
Tufts Medical Center Dept. of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical tapes: TegadermTM and EyeGard® in people with 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 29 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With Eyelid Erythema (time frame: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)). 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 NCT03549429, which also lists 1 linked publication.
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 29 Aug 2019.