Tegaderm vs. EyeGard for Eye Protection

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03549429
• Collaborator: Tufts University (Other)
• Enrollment: 159
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 98.8

Study Details

Study Description

Brief Summary

This study compares TegadermTM and EyeGard® in general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Erythema	Device: Medical tapes: TegadermTM and EyeGard®	N/A

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

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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 (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Jul 19, 2018
• Actual Study Completion Date: Jul 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TegadermTM on R eye, EyeGard® on L eye Patients will get TegadermTM on Right eye, EyeGard® on Left eye	Device: Medical tapes: TegadermTM and EyeGard®; TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
Experimental: TegadermTM on L eye, EyeGard® on R eye Patients will get TegadermTM on Left eye, EyeGard® on Right eye	Device: Medical tapes: TegadermTM and EyeGard®; TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.

Outcome Measures

Primary Outcome Measures

1. 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 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.

Secondary Outcome Measures

1. 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.

2. Rate of Corneal Abrasions [post-operation]

   Corneal abrasion is assessed in the recovery room

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center
• Tufts University

Investigators

• Principal Investigator: Dan Drzymalski, MD, Tufts Medical Center Dept. of Anesthesia

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 20, 2019

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT03549429
• Other Study ID Numbers: 12884
• First Posted: Jun 8, 2018
• Last Update Posted: Aug 29, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Erythema

Study Results

Participant Flow

Pre-assignment Detail	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)

Arm/Group Title	TegadermTM on R Eye, EyeGard® on L Eye	TegadermTM on L Eye, EyeGard® on R Eye
Arm/Group Description	Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.	Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
Period Title: Overall Study
STARTED	81	78
COMPLETED	76	75
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	TegadermTM on R Eye, EyeGard® on L Eye	TegadermTM on L Eye, EyeGard® on R Eye	Total
Arm/Group Description	Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.	Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.	Total of all reporting groups
Overall Participants	81	78	159
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 25.9%	29 37.2%	50 31.4%
>=65 years	60 74.1%	49 62.8%	109 68.6%
Sex: Female, Male (Count of Participants)
Female	41 50.6%	45 57.7%	86 54.1%
Male	40 49.4%	33 42.3%	73 45.9%
Sex: Female, Male (Count of Participants)
Female	41 50.6%	45 57.7%	86 54.1%
Male	40 49.4%	33 42.3%	73 45.9%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	65 80.2%	60 76.9%	125 78.6%
Non-Caucasian	16 19.8%	18 23.1%	34 21.4%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With Eyelid Erythema
Description	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.
Time Frame	Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)

Outcome Measure Data

Analysis Population Description

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/Group Title	Erythema With TegadermTM Only	Erythema With EyeGard® Only
Arm/Group Description	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.	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.
Measure Participants	151	151
Count of Participants [Participants]	117 144.4%	105 134.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erythema With TegadermTM Only, Erythema With EyeGard® Only
	Comments	We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	McNemar
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	8.0
	Confidence Interval	(2-Sided) 95%; 1.5 to 14.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Patient Satisfaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TegadermTM	EyeGard®
Arm/Group Description	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.	TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. 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.
Measure Participants	151	151
Mean (Standard Deviation) [Units on a scale of 1-5]	4.94 (0.42)	4.91 (0.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Erythema With TegadermTM Only, Erythema With EyeGard® Only
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	t-test, 2 sided
	Comments	paired
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Rate of Corneal Abrasions
Description	Corneal abrasion is assessed in the recovery room
Time Frame	post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TegadermTM	EyeGard®
Arm/Group Description	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.	TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia. 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.
Measure Participants	151	151
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	For the length of participation in the study; approx. 3-10 hours
Adverse Event Reporting Description	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.
Arm/Group Title	TegadermTM on R Eye, EyeGard® on L Eye		TegadermTM on L Eye, EyeGard® on R Eye
Arm/Group Description	Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.		Medical tapes: TegadermTM and EyeGard®: TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
All Cause Mortality
	TegadermTM on R Eye, EyeGard® on L Eye		TegadermTM on L Eye, EyeGard® on R Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/159 (0%)		0/159 (0%)
Serious Adverse Events
	TegadermTM on R Eye, EyeGard® on L Eye		TegadermTM on L Eye, EyeGard® on R Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/159 (0%)		0/159 (0%)
Other (Not Including Serious) Adverse Events
	TegadermTM on R Eye, EyeGard® on L Eye		TegadermTM on L Eye, EyeGard® on R Eye
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/159 (0%)		0/159 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.