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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Aging; Aging Problems; Facial Asymmetry
• Intervention / Treatment: Procedure: Limited facelift; Other: FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline; Other: FACE-Q | Aesthetics - Recovery Early Symptoms; Other: FACE-Q | Aesthetics - Satisfaction with Outcome; Other: FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck; Procedure: Full facelift

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikaela I Poling, BA; Phone Number: 7032073065; Email: research@duplastics.com
• Study Contact Backup: Name: Craig R Dufresne, MD; Phone Number: 7032073065; Email: info@duplastics.com

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Office of Craig R Dufresne, MD, PC
      • Contact: Craig R Dufresne, MD; Phone Number: 703-207-3065; Email: info@duplastics.com
      • Contact: Mikaela I Poling, BA; Phone Number: 703-207-3065; Email: research@duplastics.com
      • Principal Investigator: Craig R Dufresne, MD
      • Sub-Investigator: Mikaela I Poling, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Limited facelift; A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck; Other Names: Limited dissection SMAS manipulation; 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.
Active Comparator: 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.	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.; Procedure: Full facelift; A full face and neck lift that addresses signs of aging in the face and neck; Other Names: SMAS manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Dufresne, Craig, MD, PC
• Investigators: Principal Investigator: Craig R Dufresne, MD, Office of Dr Craig R Dufresne, MD, PC

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Rhytidoplasty; Facelift; Rhytidectomy; Superficial Musculoaponeurotic System
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Facial Asymmetry
• Other Study ID Numbers: U1111-1278-8245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: De-identified individual participant data (IPD) will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No