Tegaderm vs. Transpore Eye Tape for Eyelid Redness

Overseen By Dan Drzymalski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Eyelid trauma, Eyelid piercings, Head surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: During surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a difference exists in eyelid redness after anesthesia when using two types of eye tape: Tegaderm and Transpore. Researchers will test both tapes on patients undergoing surgery with general anesthesia to see if one causes less redness. Individuals scheduled for surgery involving anesthesia, without existing eyelid redness or trauma, may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to understanding which eye tape is more comfortable and effective during surgery.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on comparing two types of eye tape, so it's unlikely that your medications would be affected, but you should confirm with the trial organizers.

What prior data suggests that these eye tapes are safe for use on eyelids?

Research has shown that Tegaderm is generally safe for protecting the eyes, though it may cause slightly more eyelid redness than some other methods. This redness is usually mild and resolves on its own. The safety information for Tegaderm indicates no need for special eye protection or gloves, suggesting a high level of safety.

In contrast, Transpore tape has been associated with some skin problems, such as blisters, particularly in older adults or those with sensitive skin. For instance, a 72-year-old woman developed blisters on her eyelids after using Transpore tape. While these issues are uncommon, they warrant attention.

Overall, both Tegaderm and Transpore are considered safe to use, but they have different side effects. Tegaderm may cause slight redness, while Transpore may lead to skin irritation in some cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Tegaderm and Transpore eye tapes for eyelid redness because these methods offer a potential improvement in comfort and effectiveness compared to traditional eye protection options like foam pads or gauze. These tapes are designed to provide a secure and gentle hold during procedures, reducing the risk of irritation or shifting that can occur with bulkier alternatives. Additionally, the transparent nature of these tapes allows for easy monitoring of the area without removal, which is a significant advantage for maintaining eye safety and reducing handling during medical procedures.

What evidence suggests that Tegaderm and Transpore eye tapes are effective for reducing eyelid redness?

This trial will compare Tegaderm Eye Tape and Transpore Eye Tape for their effects on eyelid redness. Research has shown that Tegaderm tape might slightly increase eyelid redness after surgery compared to EyeGard. Other studies have found greater patient satisfaction with silicone tapes for skin issues around the eyes. However, Transpore tape has sometimes caused skin problems, such as blisters, on the eyelids. Despite these issues, both Tegaderm and Transpore are frequently used to protect the eyes during anesthesia. Currently, evidence is insufficient to clearly determine which tape better prevents eyelid redness. Participants in this trial will receive Tegaderm on one eye and Transpore on the other to directly compare their effects. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for surgery that requires anesthesia.

Exclusion Criteria

I will have surgery lying on my stomach.

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

Any patient that does not consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo anesthesia with Tegaderm applied to one eye and Transpore to the other

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for eyelid erythema and other changes immediately after tape removal

Immediately after surgery

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Eye Protection
• Tegaderm Eye Tape
• Transpore Eye Tape

Trial Overview 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.

How Is the Trial Designed?

Group I: Transpore Right Experimental Treatment 1 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 Left Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Published Research Related to This Trial

In a study of 60 adult patients, silicone tape caused significantly less skin injury compared to standard acrylate tapes, with only 0% experiencing skin denudation versus 13.3% with standard tapes.

Patients reported higher satisfaction with silicone tape for both eyelid and facial skin conditions, scoring an average of 4.53 and 4.57 respectively, compared to 3.83 and 3.87 for standard tapes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Medical Adhesive Tapes in Patients at Risk of Facial Skin Trauma under Anesthesia. Zeng, LA., Lie, SA., Chong, SY.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32095992/

The effect of Tegaderm™ versus EyeGard® on eyelid ... Conclusion: We found a small increase in postoperative eyelid erythema when using Tegaderm compared with EyeGard. While EyeGard could decrease the risk of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04918290

Tegaderm Vs. Transpore for Eye Protection During ... At Tufts Medical Center, a variety of adhesive tapes are used to shut the eyes during anesthesia, including 3MTM TegadermTM and the Sharn Anesthesia Transpore®, ...

3. withpower.com withpower.com/trial/phase-4-erythema-5-2021-2347e

Tegaderm vs. Transpore Eye Tape for Eyelid Redness Patients reported higher satisfaction with silicone tape for both eyelid and facial skin conditions, scoring an average of 4.53 and 4.57 respectively, compared ...

4. researchgate.net researchgate.net/publication/339463397_The_effect_of_Tegaderm_versus_EyeGardR_on_eyelid_erythema_during_general_anesthesia_a_randomized-controlled_trialEffet_du_Tegaderm_versus_EyeGardR_sur_l'erytheme_de_la_paupiere_pendant_l'anesthesie_ge

The effect of Tegaderm™ versus EyeGard® on eyelid ... Conclusion We found a small increase in postoperative eyelid erythema when using Tegaderm compared with EyeGard. While EyeGard could decrease the risk of eyelid ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03549429?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Erythema%22))))&rank=7&tab=results

NCT03549429 | Tegaderm vs. EyeGard for Eye Protection An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

6. multimedia.3m.com multimedia.3m.com/mws/mediawebserver?mwsId=SSSSSuUn_zu8l_gI4xt958tBlv70k17zHvu9lxtD7SSSSSS--

Safety Data Sheet SECTION 1: Identification SECTION 2 Eye/face protection. Eye protection not required. Skin/hand protection. No protective gloves required. Respiratory protection. Respiratory ...

7. repository.ahu.edu repository.ahu.edu/bitstreams/78f688f0-2832-4e3d-9bec-26f4ade11a6a/download

1 Preference of Eye Protection Methods among Anesthesia ... Results revealed that EyeGard was the most preferred eye protection method, used by 44.7% of respondents, followed by plastic tape at 36.2%. ...