Silicone Gel for Postsurgical Scars of the Eyelid

Scarring Due to Treatment Clinical Trial

Official title:

Efficacy of Silicone Gel Versus Placebo for Postsurgical Scars of the Eyelid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601247
• Other study ID #: 2018-9074
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 11, 2024

Study information

• Verified date: June 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix
• Scarring Due to Treatment

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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.	2 years