Tegaderm vs. EyeGard for Eye Protection

NCT03549429 | Completed Results FDA Device

• 1 other identifier: 12884
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares TegadermTM and EyeGard® in general anesthesia.

Conditions

Erythema

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)

Secondary Outcomes (2)

• Patient Satisfaction

  post-operation

• Rate of Corneal Abrasions

  post-operation

Study Arms (2)

TegadermTM on R eye, EyeGard® on L eye

EXPERIMENTAL

Patients will get TegadermTM on Right eye, EyeGard® on Left eye

Device: Medical tapes: TegadermTM and EyeGard®

TegadermTM on L eye, EyeGard® on R eye

EXPERIMENTAL

Patients will get TegadermTM on Left eye, EyeGard® on Right eye

Device: Medical tapes: TegadermTM and EyeGard®

Interventions

Medical tapes: TegadermTM and EyeGard® DEVICE

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

TegadermTM on L eye, EyeGard® on R eye; TegadermTM on R eye, EyeGard® on L eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Surgeries scheduled for anesthesia of any duration

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Tufts University: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Drzymalski DM, Ward K, Hernandez JM, Hoot J, Au SC, Yang FC, Azocar RJ. The effect of Tegaderm versus EyeGard(R) on eyelid erythema during general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):560-567. doi: 10.1007/s12630-020-01588-6. Epub 2020 Feb 13.

  PMID: 32095992 DERIVED

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Dan Drzymalski
• Organization: Tufts Medical Center

ddrzymalski@tuftsmedicalcenter.org

‪617-913-8168

Study Officials

• Dan Drzymalski, MD

  Tufts Medical Center Dept. of Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: June 1, 2018
• Primary Completion: July 19, 2018
• Study Completion: July 20, 2018
• Last Updated: August 29, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-08

Locations

US (1)