NCT05419609

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Dufresne, Craig, MD, PC · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Aging
• Facial Asymmetry
• Aging Problems

Interventions

Type	Name	Description
PROCEDURE	Limited facelift	A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck
PROCEDURE	Full facelift	A full face and neck lift that addresses signs of aging in the face and neck
OTHER	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.
OTHER	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.
OTHER	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.
OTHER	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.

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-06-15
• Last updated: 2022-07-19

Locations

1 site across 1 country: United States