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Silicone Gel for Postsurgical Scars of the Eyelid

Primary Purpose

Scarring Due to Treatment

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
silicone gel
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scarring Due to Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel.

Outcomes

Primary Outcome Measures

The appearance of post-operative scarring as graded by a blinded third-party physician using a questionnaire
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.

Secondary Outcome Measures

Rates of patient satisfaction with their post-operative scars as assessed by a questionnaire
To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars.

Full Information

First Posted
July 4, 2018
Last Updated
June 6, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03601247
Brief Title
Silicone Gel for Postsurgical Scars of the Eyelid
Official Title
Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
The PI suspended the study temporarily d/t COVID pandemic and did not want patients to attend follow-up visits at that time unless absolutely necessary. As such, the study was delayed and the PCD and SCD are being pushed out to new targeted dates.
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarring Due to Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Other
Arm Description
Split-face study: patients undergoing bilateral eye surgery will have the sides of their face randomized to receive either placebo or silicone gel.
Intervention Type
Device
Intervention Name(s)
silicone gel
Intervention Description
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 Measure Information:
Title
The appearance of post-operative scarring as graded by a blinded third-party physician using a questionnaire
Description
To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Rates of patient satisfaction with their post-operative scars as assessed by a questionnaire
Description
To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Barmettler
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Silicone Gel for Postsurgical Scars of the Eyelid

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