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Tegaderm vs. EyeGard for Eye Protection

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ClinicalTrials.gov Identifier: NCT03549429
Recruitment Status : Completed
First Posted : June 8, 2018
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Tufts University
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
This study compares TegadermTM and EyeGard® in general anesthesia.

Condition or disease Intervention/treatment Phase
Erythema Device: Medical tapes: TegadermTM and EyeGard® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : June 1, 2018
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 20, 2018

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.




Primary Outcome Measures :
  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

    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 :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549429


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Tufts University
Investigators
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Principal Investigator: Dan Drzymalski, MD Tufts Medical Center Dept. of Anesthesia
  Study Documents (Full-Text)

Documents provided by Tufts Medical Center:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03549429     History of Changes
Other Study ID Numbers: 12884
First Posted: June 8, 2018    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms