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Completed

NCT Number: NCT03549429

Tegaderm vs. EyeGard for Eye Protection

This study compares TegadermTM and EyeGard® in general anesthesia.

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Key information

Conditions

Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical tapes: TegadermTM and EyeGard®

Device

TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.

Primary outcomes

  1. Proportion of Participants With Eyelid Erythema

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: 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

    Time frame: post-operation

    Corneal abrasion is assessed in the recovery room

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Tufts University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2018
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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