Tegaderm vs. EyeGard for Eye Protection

Erythema Clinical Trial

Official title:

A Randomized Control Trial of Tegaderm vs. EyeGard for Eye Protection During General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549429
• Other study ID #: 12884
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 20, 2018

Study information

• Verified date: August 2019
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares TegadermTM and EyeGard® in general anesthesia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: July 20, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythema

Intervention

Device:
• Medical tapes: TegadermTM and EyeGard®
TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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; 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.	Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)
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.	post-operation
Secondary	Rate of Corneal Abrasions	Corneal abrasion is assessed in the recovery room	post-operation