Edema Face Clinical Trial
Official title:
Malar Bags After Lower Lid Blepharoplasty and Facelift: A Randomized Controlled Trial of the Effects of Tacrolimus
Elective lower eyelid surgery is a common cosmetic procedure. Facial swelling is a common complication. Studies suggest that this facial swelling is part of a complex inflammatory process. Topical tacrolimus has long been used to treat various inflammatory skin disorders. By combining our knowledge of facial swelling and tacrolimus mechanism of action, we can hypothesize that it can be used as a treatment to prevent this post-operative swelling. The purpose of this project is to apply topical tacrolimus to one of the patient's cheeks following facial surgery and compare the incidence of facial swelling to the opposite side control cheek.
1.0 Purpose:
To perform a randomized controlled trial to determine if topical tacrolimus ointment reduces
incidence or severity of post-operative facial edema and malar bags after elective
blepharoplasty and/or facelift.
2.0 Hypothesis:
Topical tacrolimus will reduce the incidence and severity of post-operative facial edema
presenting as malar bags after blepharoplasty and/or facelift.
3.0 Justification:
Elective blepharoplasty is the fourth most common cosmetic procedures performed in North
America. According to a report published by the American Society of Plastic Surgery, eye lid
surgery accounted for 209,000 out of the 1.7 million cosmetic surgical procedures performed
in 2016. Additionally, the number of eye lid surgeries rose 2% in 2016 compared to 2015 [ref
1].
Recurrent or worsened malar bags is a common complication of lower lid surgery. Studies
suggest that post-operative lymphedema is a possible cause of these malar bags. Recent
research into lymphedema pathophysiology shows that post-operative lymphedema is not simply a
result of direct lymphatic injury, but rather a complex fibroproliferative inflammatory
process.
Topical tacrolimus has long been used to treat various inflammatory skin disorders such as
atopic dermatitis and psoriasis safely and effectively. By combining our knowledge of
lymphedema pathophysiology and tacrolimus mechanism of action, we can hypothesize that it can
be effectively used as a treatment to prevent post-operative malar bags as a result of
lymphedema.
4.0 Objectives:
4.1. To apply topical tacrolimus ointment to a randomized cheek in sequential patients
undergoing lower lid blepharoplasty, facelift or both and compare to the contralateral
control cheek.
4.2. To determine if topical tacrolimus affects the incidence and severity of post-operative
malar edema compared to the self-matched contralateral control cheek.
5.0 Research Design:
This is a double blinded randomized controlled trial involving an initial surgery followed by
random topical drug treatment that is self matched to a contralateral control side. There
will be 3 follow up visits for analysis.
6.0 Statistical Analysis:
6.1 Statistical Considerations
The primary endpoint is post operative malar edema which typically occurs 10-20% of the time
following lower lid blepharoplasty and/or facelift procedures. If we expect to reduce the
occurrence to 1-5% the number of patients required to achieve a significant result (α = 0.05
(2-sided), β = 0.20) is 40-100.
No increase in sample size has been made to account for losses to follow-up. In our practice
over the past 10 years we have found that less than 1% of patients do not return for a
follow-up visit.
6.2 Outcome Measures
A custom four point scale will be used to record the outcomes for each cheek:
I: No post operative edema. II: Mild post operative edema. III: Moderate post operative
edema. IV: Severe post operative edema.
Example photographs will be provided to the blinded rater for each category.
6.3 Data Collection
Outcome measurements will be performed by a single observer who will be blinded to the
contents of the containers and which cheek either was applied to. Data will be collected on
study specific data collection forms.
7.0 Procedure
7.1 Surgical Procedure
The lower lid blepharoplasty and facelift procedures will be performed by Dr. Richard Warren
in the usual fashion based on the patient's presenting problem. Specific differences in
technique such as skin only excision vs fat transposition and ORL (Orbicularis Retaining
Legament) division will be recorded and analyzed separately.
7.2 Tacrolimus Application
Patients will be given two containers labelled with "Right" and "Left" to be applied to their
right and left cheeks respectively. The patients will apply the ointment once daily for 4
weeks post operatively. The contents of the containers will be randomized to either the
treatment tacrolimus ointment or the control ointment which will be matched in colour and
consistency to the tacrolimus ointment. They will be given instructions on applying the
ointments based on FDA recommendations.
7.3 Choice of Tacrolimus Dose
The treatment containers will contain 0.1% tacrolimus ointment (marketed as PROTOPIC) based
on FDA recommendations for adult patients. This dose of the drug is known to be sufficiently
absorbed by inflamed skin reaching peak concentrations of 0.05-0.25ng/ml 3-6 hours after
application. This is significantly lower than the accepted safe level of 5-20ng/ml
established based on transplant research. [ref 16,17]
7.4 Post-operative Treatment
Patients will be followed post operatively in the office at 1 week, 4 weeks, and 6 months.
Degree of post operative malar edema will be assessed by a single blinded observer. This will
be recorded using a four point scale. Any side effects or adverse events will also be
recorded.
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