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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Office-based limited facelift | Experimental | Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication. |
|
| Hospital-based full facelift | Active Comparator | Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limited facelift | Procedure | A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikaela I Poling, BA | Contact | 7032073065 | research@duplastics.com | |
| Craig R Dufresne, MD | Contact | 7032073065 | info@duplastics.com |
| Name | Affiliation | Role |
|---|---|---|
| Craig R Dufresne, MD | Office of Dr Craig R Dufresne, MD, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Office of Craig R Dufresne, MD, PC | Recruiting | Fairfax | Virginia | 22031 | United States |
De-identified individual participant data (IPD) will not be available to other researchers.
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| Full facelift | Procedure | A full face and neck lift that addresses signs of aging in the face and neck |
|
|
| FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline | Other | 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. |
|
| FACE-Q | Aesthetics - Recovery Early Symptoms | Other | 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. |
|
| FACE-Q | Aesthetics - Satisfaction with Outcome | Other | 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. |
|
| FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck | Other | 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. |
|
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D005146 | Facial Asymmetry |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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