Erythema
Conditions
Brief summary
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.
Interventions
DEVICEMedical tapes: TegadermTM and EyeGard®
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
Sponsors
Tufts University
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 * Eyelid piercings * Any surgery on the head, brain, neck, teeth, mouth, eyes or face * Surgery in the prone position * Patients \<18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Eyelid Erythema | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | post-operation | 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. |
| Rate of Corneal Abrasions | post-operation | Corneal abrasion is assessed in the recovery room |
Countries
United States
Participant flow
Pre-assignment details
A total of 159 patients were enrolled (consented) but not randomized. The reasons for not randomizing include: * Research assistant unavailable (n=6) * Anesthetic plan change (n=4) * Surgical plan change (n=4) * Tape sensitivity (n=1)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 81 |
| 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. | 78 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 5 | 3 |
Baseline characteristics
| Characteristic | TegadermTM on R Eye, EyeGard® on L Eye | TegadermTM on L Eye, EyeGard® on R Eye | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 60 Participants | 49 Participants | 109 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 29 Participants | 50 Participants |
| Race/Ethnicity, Customized Caucasian | 65 Participants | 60 Participants | 125 Participants |
| Race/Ethnicity, Customized Non-Caucasian | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Female | 41 Participants | 45 Participants | 86 Participants |
| Sex: Female, Male Male | 40 Participants | 33 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 0 / 159 |
| other Total, other adverse events | 0 / 159 | 0 / 159 |
| serious Total, serious adverse events | 0 / 159 | 0 / 159 |
Outcome results
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 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.
Time frame: Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erythema With TegadermTM Only | Proportion of Participants With Eyelid Erythema | 117 Participants |
| Erythema With EyeGard® Only | Proportion of Participants With Eyelid Erythema | 105 Participants |
Comparison: We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.p-value: 0.0395% CI: [1.5, 14.4]McNemar
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.
Time frame: post-operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erythema With TegadermTM Only | Patient Satisfaction | 4.94 Units on a scale of 1-5 | Standard Deviation 0.42 |
| Erythema With EyeGard® Only | Patient Satisfaction | 4.91 Units on a scale of 1-5 | Standard Deviation 0.51 |
p-value: 0.23t-test, 2 sided
Secondary
Rate of Corneal Abrasions
Corneal abrasion is assessed in the recovery room
Time frame: post-operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Erythema With TegadermTM Only | Rate of Corneal Abrasions | 0 Participants |
| Erythema With EyeGard® Only | Rate of Corneal Abrasions | 0 Participants |