Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift

Study Overview
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Brief Summary
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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
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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.

Official Title
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Office-based Limited Dissection SMAS Manipulation Under Local Anesthesia Versus Facility-based SMAS Manipulation: a Single-surgeon, Random-assignment Non-inferiority Study

Conditions
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Skin Aging, Facial Asymmetry, Aging Problems

Intervention / Treatment
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* Procedure: Limited facelift
* Procedure: Full facelift
* Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline
* Other: FACE-Q | Aesthetics - Recovery Early Symptoms
* Other: FACE-Q | Aesthetics - Satisfaction with Outcome
* Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Office-based limited facelift<br>Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication. | Procedure: Limited facelift<br>* A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck<br>* Other names: Limited dissection SMAS manipulation;Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline<br>* 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.<br>Other: FACE-Q | Aesthetics - Recovery Early Symptoms<br>* 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.<br>Other: FACE-Q | Aesthetics - Satisfaction with Outcome<br>* 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.<br>Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck<br>* 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.<br>|
| Active Comparator: Hospital-based full facelift<br>Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation. | Procedure: Full facelift<br>* A full face and neck lift that addresses signs of aging in the face and neck<br>* Other names: SMAS manipulation;Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline<br>* 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.<br>Other: FACE-Q | Aesthetics - Recovery Early Symptoms<br>* 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.<br>Other: FACE-Q | Aesthetics - Satisfaction with Outcome<br>* 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.<br>Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhytidoplasty, Facelift, Rhytidectomy, Superficial Musculoaponeurotic System