Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift
NCT ID: NCT05419609
Last Updated: 2022-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-06-30
2023-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Limited facelift
A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck
FACE-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.
FACE-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.
FACE-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.
FACE-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.
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.
Full facelift
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
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
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
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
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.
Interventions
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Limited facelift
A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck
Full facelift
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
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
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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
85 Years
ALL
Yes
Sponsors
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Dufresne, Craig, MD, PC
OTHER
Responsible Party
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Principal Investigators
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Craig R Dufresne, MD
Role: PRINCIPAL_INVESTIGATOR
Office of Dr Craig R Dufresne, MD, PC
Locations
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Office of Craig R Dufresne, MD, PC
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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U1111-1278-8245
Identifier Type: -
Identifier Source: org_study_id
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