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Silicone Gel for Postsurgical Scars of the Eyelid

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ClinicalTrials.gov Identifier: NCT03601247
Recruitment Status : Suspended (The principal investigator suspended the study temporarily because of the COVID pandemic. We do not want patients to attend their follow-up visits at this time unless absolutely necessary.)
First Posted : July 26, 2018
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Brief Summary:
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

Condition or disease Intervention/treatment Phase
Scarring Due to Treatment Device: silicone gel Not Applicable

Detailed Description:

Upper eyelid blepharoplasty or ptosis repair is performed when the upper eyelid becomes droopy, which often occurs as a natural part of the aging process. The droopiness of the upper eyelids decreases the ability to see objects in their peripheral vision, causing functional deficits. Additionally, the droopiness can be a cosmetic concern for many. The most effective treatment option is blepharoplasty or ptosis repair.

During routine pre-operative counseling, many patients note a fear of prominent facial scarring. Different techniques have been described in the literature to minimize scarring, from steroid creams to injections to laser therapy; however, there is currently no consensus for long-term management of post-surgical eyelid scars. Specifically, there is no study examining the efficacy of topical silicone gel on eyelid scars, although a few studies have examined its efficacy on other facial scars. Silicone is proposed to aid in healing by regulating fibroblast production, reducing collagen production, and modifying expression of growth factors.

The investigator's study is designed to determine whether topical silicone may prevent significant post-operative eyelid scar formation. It may help clarify whether there is a safe and effective topical treatment for patients undergoing eyelid surgery for whom scarring or cosmesis is a concern. It is the first study of silicone gel on the eyelid and is also prospective, randomized, and double blinded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : May 20, 2022
Estimated Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
All patients
Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel.
Device: silicone gel
Patients who have consented to the study will receive two tubes labeled only "left" and "right", corresponding to the side of the face to which the tube contents will be applied. One tube will contain silicone gel and the other tube will contain aquaphor. Neither the patient nor the surgeon will know what side will receive which treatment. These tubes will be given to patients at post-operative week 1 visit. Patients will be instructed to rub the solution into their eyelid incisions gently with their fingers for 2-3 minutes twice a day




Primary Outcome Measures :
  1. The appearance of post-operative scarring as graded by a blinded third-party physician using a questionnaire [ Time Frame: 2 years ]
    To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.


Secondary Outcome Measures :
  1. Rates of patient satisfaction with their post-operative scars as assessed by a questionnaire [ Time Frame: 2 years ]
    To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars.



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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:

  • Patients will be included if they have met the criteria for undergoing upper eyelid ptosis repair or blepharoplasty. This means they have droopiness of the upper eyelids that is visually significant and limiting the patient's visual field.

Exclusion Criteria:

  • Patients will be excluded if they require additional upper eyelid surgery.

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): NCT03601247


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Anne Barmettler Montefiore
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03601247    
Other Study ID Numbers: 2018-9074
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes