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| Name | Class |
|---|---|
| Tufts University | OTHER |
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This study compares TegadermTM and EyeGard® in general anesthesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TegadermTM on R eye, EyeGard® on L eye | Experimental | Patients will get TegadermTM on Right eye, EyeGard® on Left eye |
|
| TegadermTM on L eye, EyeGard® on R eye | Experimental | Patients will get TegadermTM on Left eye, EyeGard® on Right eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical tapes: TegadermTM and EyeGard® | Device | TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | post-operation |
| Rate of Corneal Abrasions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Drzymalski, MD | Tufts Medical Center Dept. of Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32095992 | Derived | 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. |
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A total of 159 patients were enrolled (consented) but not randomized. The reasons for not randomizing include:
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| ID | Title | Description |
|---|---|---|
| FG000 | TegadermTM on R Eye, EyeGard® on L Eye | Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. |
| FG001 | TegadermTM on L Eye, EyeGard® on R Eye | Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Those who were eligible were analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | TegadermTM on R Eye, EyeGard® on L Eye | Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. |
| BG001 | TegadermTM on L Eye, EyeGard® on R Eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Inclusion Criteria: Age ≥ 18, 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/piercings, any surgery on the head, brain, neck, teeth, mouth, eyes or face, surgery in the prone position, patients <18 years old | Posted | Count of Participants | Participants | Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration) |
|
For the length of participation in the study; approx. 3-10 hours
This study does not pose any additional safety risks beyond those associated with the application of protective tape over the patient's eyelids that occurs during standard surgical procedures. These risks include injury to the eyelid such as mild to severe erythema, edema, and abrasion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TegadermTM on R Eye, EyeGard® on L Eye | Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dan Drzymalski | Tufts Medical Center | 617-913-8168 | ddrzymalski@tuftsmedicalcenter.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2019 | Aug 20, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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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.
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Corneal abrasion is assessed in the recovery room |
| post-operation |
Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. Half of the participants (n=76) will receive TegadermTM over their right eyelid and EyeGard over the left eyelid. The other half of the participants (n=75) will receive TegadermTM over their left eyelid and EyeGard over the right eyelid. |
| OG001 | Erythema With EyeGard® Only | TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. Half of the participants (n=76) will receive TegadermTM over their right eyelid and EyeGard over the left eyelid. The other half of the participants (n=75) will receive TegadermTM over their left eyelid and EyeGard over the right eyelid. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale of 1-5 | post-operation |
|
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| Secondary | Rate of Corneal Abrasions | Corneal abrasion is assessed in the recovery room | Posted | Count of Participants | Participants | post-operation |
|
|
|
| 0 |
| 159 |
| 0 |
| 159 |
| 0 |
| 159 |
| EG001 | TegadermTM on L Eye, EyeGard® on R Eye | Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. | 0 | 159 | 0 | 159 | 0 | 159 |
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| D013568 | Pathological Conditions, Signs and Symptoms |