Silicone Gel for Postsurgical Scars of the Eyelid

NCT03601247 | Completed Results DMC FDA Device

• 1 other identifier: 2018-9074
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scarring Due to Treatment

Outcome Measures

Primary Outcomes (3)

• Post-operative Scarring - Erythema

  To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Erythema, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1 = none", "2 = pink", and "3 = red". Higher mean scores are associated with increased redness.

  Up to 6 months post-operation

• Post-operative Scarring - Elevation

  To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Elevation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=no elevation", "2=minimal elevation (\<0.5 mm)", and "3=definite elevation (\>0.5 mm)". Higher mean scores are associated with increased elevation.

  Up to 6 months post-operation

• Post-operative Scarring - Pigmentation

  To determine whether silicone gel is effective at preventing or minimizing scar formation after eyelid surgery the appearance of post-operative Pigmentation, as graded by a blinded third-party physician using a questionnaire, was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively. Physicians could choose between "1=normal" and 2= hyper- or hypo-pigmentation". Higher/lower mean scores are associated with increased/decreased pigmentation, respectively.

  6 months post-operation

Secondary Outcomes (4)

• Patient Satisfaction

  Up to 6 months post-operation

• Post-operative Itching

  Up to 6 months post-operation

• Post-Operative Pain

  Up to 6 months post-operation

• Patient Scar Preference

  6 months post-operation

Other Outcomes (1)

• Post-operative Firmness

  Up to 6 months post-operation

Study Arms (1)

All patients

OTHER

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

Interventions

silicone gel DEVICE

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Had prior eyelid surgery
• Undergoing additional upper eyelid surgery
• Using topical treatments on the upper eyelids that would interfere with the investigation

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (4)

• Murdock J, Sayed MS, Tavakoli M, Portaliou DM, Lee WW. Safety and efficacy of a growth factor and cytokine-containing topical product in wound healing and incision scar management after upper eyelid blepharoplasty: a prospective split-face study. Clin Ophthalmol. 2016 Jun 30;10:1223-8. doi: 10.2147/OPTH.S109517. eCollection 2016.

  PMID: 27418806 BACKGROUND

• Bianchi FA, Roccia F, Fiorini P, Berrone S. Use of Patient and Observer Scar Assessment Scale for evaluation of facial scars treated with self-drying silicone gel. J Craniofac Surg. 2010 May;21(3):719-23. doi: 10.1097/SCS.0b013e3181d841af.

  PMID: 20485035 BACKGROUND

• Yun IS, Yoo HS, Kim YO, Rah DK. Improved scar appearance with combined use of silicone gel and vitamin C for Asian patients: a comparative case series. Aesthetic Plast Surg. 2013 Dec;37(6):1176-81. doi: 10.1007/s00266-013-0210-5. Epub 2013 Oct 3.

  PMID: 24091488 BACKGROUND

• Puri N, Talwar A. The efficacy of silicone gel for the treatment of hypertrophic scars and keloids. J Cutan Aesthet Surg. 2009 Jul;2(2):104-6. doi: 10.4103/0974-2077.58527.

  PMID: 20808600 BACKGROUND

Limitations and Caveats

Limitations in sample size, follow-up time, and subject retention should be noted. Future studies in this area could include extended follow-up periods, larger sample sizes, and exploration of combination therapies, such as silicone gel in conjunction with other modalities of scar management.

Results Point of Contact

• Title: Dr. Anne Barmettler
• Organization: Montefiore Medical Center

annebarmett@montefiore.org

7189205561

Study Officials

• Anne Barmettler

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)