Clinical trial NCT05419609: Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift
Official title: Office-based Limited Dissection SMAS Manipulation Under Local Anesthesia Versus Facility-based SMAS Manipulation: a Single-surgeon, Random-assignment Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Facial Asymmetry
Aging Problems
Keywords: Rhytidoplasty
Facelift
Rhytidectomy
Superficial Musculoaponeurotic System
Lead sponsor: Dufresne, Craig, MD, PC
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects
timeFrame: 1 hour following surgery and 2 weeks following surgery
measure: Difference in post-operative aesthetic correction rating between groups
timeFrame: an average of 1 year following surgery
Secondary outcomes:
measure: Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit
timeFrame: an average of 30 days before surgery and again an average of 1 year following surgery
Other outcomes:
measure: Difference of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" baseline and last post-operative visit scores between groups
timeFrame: an average of 30 days before surgery and again an average of 1 year following surgery
measure: Difference of "FACE-Q - Recovery Early Symptoms" scores between groups
timeFrame: 1 week following surgery
measure: Difference of "FACE-Q | Aesthetics - Satisfaction with Outcome" scores between groups
timeFrame: an average of 1 year following surgery
measure: Difference of "FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck" scores between groups
timeFrame: an average of 1 year following surgery
Locations:
city: Fairfax
country: United States
facility: Office of Craig R Dufresne, MD, PC
state: Virginia
Study officials:
affiliation: Office of Dr Craig R Dufresne, MD, PC
name: Craig R Dufresne, MD
role: PRINCIPAL_INVESTIGATOR
References: