Scarring Due to Treatment
Conditions
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.
Interventions
DEVICEsilicone 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
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
* Had prior eyelid surgery * Undergoing additional upper eyelid surgery * Using topical treatments on the upper eyelids that would interfere with the investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Scarring - Erythema | Up to 6 months post-operation | 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. |
| Post-operative Scarring - Elevation | Up to 6 months post-operation | 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. |
| Post-operative Scarring - Pigmentation | 6 months post-operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Up to 6 months post-operation | To determine whether silicone gel treatment has any effect on patient satisfaction with post-surgical eyelid scars patient satisfaction with post-operative scars was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via a questionnaire. Patients could choose between "1=very dissatisfied", "2=dissatisfied", "3=neutral", "4=satisfied", "5=very satisfied." |
| Post-operative Itching | Up to 6 months post-operation | Post-operative Itching was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medication". Higher mean scores are associated with increased itching. |
| Post-Operative Pain | Up to 6 months post-operation | Post-operative Pain was assessed at 1 week, 1 month, 3 months, and 6 months post-operatively via patient-reported surveys during follow-up visits. Patients could choose between "1=none", "2=occasional", and "3=requires medical attention". Higher mean scores are associated with increased pain. |
| Patient Scar Preference | 6 months post-operation | To determine whether silicone gel treatment has any effect on patient preference of post-surgical eyelid scar treatment, patient preference with scars at 1 week, 1 month, and 6 months post-operation was assessed by a questionnaire. Blinded patients could choose "right" or "left" or "neither". Non-blinded coders then converted patient responses to "Silicone Gel treatment preferred" or "Placebo treatment preferred" or "Neither treatment preferred" based on each patient's eye randomization. The number of patients in each categorical variable is summarized by study arm. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnne Barmettler
Montefiore Medical Center
Participant flow
Recruitment details
In this prospective, double-blinded split-face randomized study, patients who had already consented to undergoing surgical repair of upper eyelid ptosis or blepharoplasty were asked by the surgeon/principal investigator (PI) if they wished to participate in the study. The informed consent process took place in the PI's office after routine pre-operative counseling and discussion was performed for repair of upper eyelid ptosis or blepharoplasty.
Pre-assignment details
Based on the "split face" study design, there were 96 participants in each arm. Each participant served as their own control and had silicone gel applied to one eye and placebo treatment applied to the other eye. There was no attrition between consent/enrollment and randomization. Attrition after randomization is summarized in the tables below.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65 Years STANDARD_DEVIATION 9.2 |
| Race/Ethnicity, Customized Black | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 63 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Prefer not to specify | 10 Participants |
| Race/Ethnicity, Customized White | 8 Participants |
| Region of Enrollment United States | 96 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
None listed