What side effects are associated with this type of intervention?

Treatments for eyelid redness, such as the use of adhesive products like TegadermTM and Transpore®, can cause side effects including skin irritation, erythema, and potential allergic reactions. Other common treatments, such as topical antibiotics or steroids, may lead to local irritation, dryness, and occasionally more severe allergic reactions.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments targeting eyelid redness that are similar to TegadermTM and Transpore®. However, these products are used to protect the skin during anesthesia, suggesting their role in minimizing skin reactions such as erythema. For broader treatments of skin conditions involving redness, topical agents like tacrolimus and mometasone furoate have shown efficacy in reducing erythema in conditions like dermatitis.

What other types of research exist?

Promising novel alternatives to TegadermTM and Transpore® for eyelid redness include silicone-based adhesives and hydrocolloid dressings. Silicone adhesives are known for their gentle adherence and reduced risk of skin irritation, making them suitable for sensitive areas like the eyelids. Hydrocolloid dressings provide a moist environment that can help reduce erythema and promote healing. Both options offer improved skin compatibility and comfort compared to traditional adhesives.

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Tegaderm vs. Transpore Eye Tape for Eyelid Redness

N/A

Waitlist Available

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgeries scheduled for anesthesia of any duration

At least 18 years old

Must not have

Surgery in the prone position

Any surgery on the head, brain, neck, teeth, mouth, eyes, or face

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after tape removal

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of medical tapes used to keep patients' eyes closed during surgery. It aims to find out which tape causes less eyelid irritation in patients undergoing anesthesia.

Who is the study for?

This trial is for adults over 18 who are scheduled for any surgery requiring anesthesia, except surgeries involving the head, neck, face, eyes or mouth. It's not for those with pre-existing eyelid redness or trauma, eyelid piercings, or anyone undergoing surgery in a prone position.

What is being tested?

The study aims to compare Tegaderm Eye Tape and Transpore Eye Tape to see if there's a difference in causing eyelid redness after anesthesia. Participants will be randomly assigned one of the two tapes during their procedure.

What are the potential side effects?

Potential side effects may include irritation at the tape application site leading to redness of the eyelids (eyelid erythema) following removal post-anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery that requires anesthesia.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I will have surgery lying on my stomach.

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I have had surgery on my head, brain, neck, teeth, mouth, eyes, or face.

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I have redness or injury on my eyelid.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after tape removal

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after tape removal

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after tape removal for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore

Secondary study objectives

Edema

Epidermal Change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transpore RightExperimental Treatment1 Intervention

After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye.

Group II: Tegaderm LeftExperimental Treatment1 Intervention

After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tegaderm Eye Tape

2021

N/A

~170

Transpore Eye Tape

2021

N/A

~170

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for eyelid redness include topical antibiotics, anti-inflammatory agents, and protective barriers like TegadermTM and Transpore®. Topical antibiotics, such as erythromycin, work by reducing bacterial load and preventing infection. Anti-inflammatory agents, like corticosteroids, decrease inflammation and redness by suppressing the immune response. Protective barriers, such as TegadermTM and Transpore®, shield the skin from external irritants and help maintain a moist environment, promoting healing. These treatments are crucial for patients with eyelid redness as they address the underlying causes of redness, reduce symptoms, and prevent complications.

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