Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift (COAL2)

Dufresne, Craig, MD, PC

Status: Enrolling

Conditions: Skin Aging; Aging Problems; Facial Asymmetry

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05419609

U1111-1278-8245

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Office-based limited facelift

Experimental group

Description:

Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.

Treatment:

Other: FACE-Q | Aesthetics - Satisfaction with Outcome

Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck

Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline

Other: FACE-Q | Aesthetics - Recovery Early Symptoms

Procedure: Limited facelift

Hospital-based full facelift

Active Comparator group

Description:

Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.

Treatment:

Other: FACE-Q | Aesthetics - Satisfaction with Outcome

Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck

Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline

Procedure: Full facelift

Other: FACE-Q | Aesthetics - Recovery Early Symptoms