Office-based Limited Dissection SMAS Manipulation Under Local Anesthesia Versus Facility-based SMAS Manipulation: a Single-surgeon, Random-assignment Non-inferiority Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Dufresne, Craig, MD, PC
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Difference in post-operative aesthetic correction rating between groups
Study Overview
Brief Summary
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.
Detailed Description
While there are previous reports of facelift in an office-based setting without general anesthesia or intravenous sedation, these reports included patient demographic information, medical history, and complication rates only and did not compare their office-based facelift with a full facelift done in the hospital or ambulatory surgical center. Previous reports also included oral sedation for all patients.
The current study will address these gaps in what is known about office-based limited facelifts done with local anesthesia. Finally, the study will also ascertain patient satisfaction at 3 points-at the pre-operative visit, early post-operative visit, and final visit-using selected modules from the validated FACE-Q | Aesthetics survey.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
- •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
Arms & Interventions
Office-based limited facelift
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Intervention: Limited facelift (Procedure)
Office-based limited facelift
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Intervention: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline (Other)
Office-based limited facelift
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Intervention: FACE-Q | Aesthetics - Recovery Early Symptoms (Other)
Office-based limited facelift
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Intervention: FACE-Q | Aesthetics - Satisfaction with Outcome (Other)
Office-based limited facelift
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Intervention: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck (Other)
Hospital-based full facelift
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Intervention: Full facelift (Procedure)
Hospital-based full facelift
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Intervention: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline (Other)
Hospital-based full facelift
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Intervention: FACE-Q | Aesthetics - Recovery Early Symptoms (Other)
Hospital-based full facelift
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Intervention: FACE-Q | Aesthetics - Satisfaction with Outcome (Other)
Hospital-based full facelift
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Intervention: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck (Other)
Outcomes
Primary Outcomes
Difference in post-operative aesthetic correction rating between groups
Time Frame: an average of 1 year following surgery
Post-operative aesthetic correction rating is completed based on comparison with pre-operative photographs. Ratings possible are 1 (no improvement) to 5 (excellent).
Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects
Time Frame: 1 hour following surgery and 2 weeks following surgery
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.
Secondary Outcomes
- Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit(an average of 30 days before surgery and again an average of 1 year following surgery)