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

Skin Aging Clinical Trial

— COAL2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419609
• Other study ID #: U1111-1278-8245
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: July 2023

Study information

• Verified date: July 2022
• Source: Dufresne, Craig, MD, PC
• Contact: Mikaela I Poling, BA
• Phone: 7032073065
• Email: research[@]duplastics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Problems
• Facial Asymmetry
• Skin Aging

Intervention

Procedure:
• 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

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.
• 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.

Locations

Country	Name	City	State
United States	Office of Craig R Dufresne, MD, PC	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Dufresne, Craig, MD, PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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