Tegaderm vs. EyeGard for Eye Protection

Not Applicable

Completed

• Conditions: Erythema

• Registration Number: NCT03549429
• Lead Sponsor: Tufts Medical Center

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.

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Study Start: 2018-06-01
• Study First Posted: 2018-06-08
• Primary Completion: 2018-07-19
• Study Completion: 2018-07-20
• Results First Submitted: 2019-06-12
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-16
• Results First Posted: 2019-08-20
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States