Skin Aging Clinical Trial
— COAL2Official title:
Office-based Limited Dissection SMAS Manipulation Under Local Anesthesia Versus Facility-based SMAS Manipulation: a Single-surgeon, Random-assignment Non-inferiority Study
To compare safety, patient satisfaction, and technical correction between a limited and full facelift, patients meeting strict clinical and safety criteria for both types of facelift will be randomly assigned to have one of these procedures. In the context of this study, a limited facelift is done in the office under local anesthesia, and a full facelift is done in the hospital or ambulatory surgical center with either general anesthesia or intravenous sedation.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patient willing to randomly undergo either a limited facelift done in the office or a full facelift done in the hospital - Patient willing and able to accept financial responsibilities of undergoing either type of facelift. - Patient able to provide informed consent - Between age 40-years-old and 85-years-old - No history of bleeding disorder - BMI <25 - Stable weight - Does not have implanted cardiac device - Minimal anxiety - No history of smoking - Stable, good health - Normal blood pressure or well-controlled hypertension - Surgeon believes patient could tolerate and safely undergo either a limited facelift done in the office or a full facelift done in the hospital Exclusion Criteria: - Patient refusal to randomly undergo either a limited facelift done in the office or a full facelift done in the hospital - Patient not willing or not able to accept financial responsibilities of undergoing either type of facelift. - Patient unable to provide informed consent - Under age 40-years-old or over 85-years-old - History of bleeding disorder - BMI >25 - Unstable weight - Has implanted cardiac device - Significant anxiety - History of smoking - Significant active disease (e.g., dementia, cancer, chronic respiratory illness, heart disease, etc.) - Uncontrolled hypertension - Surgeon believes patient could not tolerate or safely undergo either a limited facelift done in the office or a full facelift done in the hospital |
Country | Name | City | State |
---|---|---|---|
United States | Office of Craig R Dufresne, MD, PC | Fairfax | Virginia |
Lead Sponsor | Collaborator |
---|---|
Dufresne, Craig, MD, PC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difference of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" baseline and last post-operative visit scores between groups | The "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" is a validated patient satisfaction survey for the lower face and jawline. | an average of 30 days before surgery and again an average of 1 year following surgery | |
Other | Difference of "FACE-Q - Recovery Early Symptoms" scores between groups | The "FACE-Q - Recovery Early Symptoms" is a validated patient satisfaction survey for the early post-operative period following aesthetic facial procedures. | 1 week following surgery | |
Other | Difference of "FACE-Q | Aesthetics - Satisfaction with Outcome" scores between groups | The "FACE-Q | Aesthetics - Satisfaction with Outcome" is a validated patient satisfaction survey for final outcomes following aesthetic facial procedures. | an average of 1 year following surgery | |
Other | Difference of "FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck" scores between groups | FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck" is a validated patient satisfaction survey for chronic adverse post-operative events following aesthetic facial procedures. | an average of 1 year following surgery | |
Primary | Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects | Post-operative adverse effects may be acute, such as hematoma or infection, or they may become apparent later, such as nerve injury. Not all post-operative adverse effects will require treatment, such as mild pain, swelling, or bruising. | 1 hour following surgery and 2 weeks following surgery | |
Primary | Difference in post-operative aesthetic correction rating between groups | Post-operative aesthetic correction rating is completed based on comparison with pre-operative photographs. Ratings possible are 1 (no improvement) to 5 (excellent). | an average of 1 year following surgery | |
Secondary | Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit | The "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" is a validated patient satisfaction survey for the lower face and jawline. | an average of 30 days before surgery and again an average of 1 year following surgery |
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