Aging Problems, Facial Asymmetry, Skin Aging
Conditions
Keywords
Rhytidoplasty, Facelift, Rhytidectomy, Superficial Musculoaponeurotic System
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.
Interventions
PROCEDURELimited facelift
A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck
PROCEDUREFull facelift
A full face and neck lift that addresses signs of aging in the face and neck
OTHERFACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline
Completed by patients. The FACE-Q \| Aesthetics - Satisfaction With Lower Face and Jawline is a 5-item questionnaire. Each item is rated 1-4, with 1 being Very Dissatisfied and 4 being Very Satisfied. Lower scores suggest the person may be less pleased with the appearance of their lower face and jawline.
OTHERFACE-Q | Aesthetics - Recovery Early Symptoms
Completed by patients. The FACE-Q \| Aesthetics - Recovery Early Symptoms is a 17-item questionnaire. Each item is rated 1-4, with 1 being Not at all and 4 being Extremely. Lower scores suggest the person may be experiencing fewer symptoms early in their recovery following an aesthetic facial procedure.
OTHERFACE-Q | Aesthetics - Satisfaction with Outcome
Completed by patients. The FACE-Q \| Aesthetics - Satisfaction with Outcome is a 6-item questionnaire. Each item is rated 1-4, with 1 being Definitely disagree and 4 being Definitely agree. Lower scores suggest the person may be less pleased with their final appearance following surgery and the decision to have an aesthetic facial procedure.
OTHERFACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck
Completed by patients. The FACE-Q \| Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck is a 15-item questionnaire. Each item is rated 1-3, with 1 being Not at all and 3 being A lot. Lower scores suggest the person may be experiencing fewer chronic symptoms following an aesthetic facial procedure.
Sponsors
Dufresne, Craig, MD, PC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects | 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. |
| Difference in post-operative aesthetic correction rating between groups | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The FACE-Q \| Aesthetics - Satisfaction With Lower Face and Jawline is a validated patient satisfaction survey for the lower face and jawline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference of FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline baseline and last post-operative visit scores between groups | an average of 30 days before surgery and again an average of 1 year following surgery | The FACE-Q \| Aesthetics - Satisfaction With Lower Face and Jawline is a validated patient satisfaction survey for the lower face and jawline. |
| Difference of FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck scores between groups | an average of 1 year following surgery | 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. |
| Difference of FACE-Q - Recovery Early Symptoms scores between groups | 1 week following surgery | The FACE-Q - Recovery Early Symptoms is a validated patient satisfaction survey for the early post-operative period following aesthetic facial procedures. |
| Difference of FACE-Q | Aesthetics - Satisfaction with Outcome scores between groups | an average of 1 year following surgery | The FACE-Q \| Aesthetics - Satisfaction with Outcome is a validated patient satisfaction survey for final outcomes following aesthetic facial procedures. |
Countries
United States
Contacts
Primary ContactMikaela I Poling, BA
Backup ContactCraig R Dufresne, MD
Outcome results
None listed