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

NCT05419609 | Unknown

• 1 other identifier: U1111-1278-8245
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Aging; Facial Asymmetry; Aging Problems

Keywords

Rhytidoplasty; Facelift; Rhytidectomy; Superficial Musculoaponeurotic System

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit

  an average of 30 days before surgery and again an average of 1 year following surgery

Other Outcomes (4)

• Difference of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" baseline and last post-operative visit scores between groups

  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

  1 week following surgery

• Difference of "FACE-Q | Aesthetics - Satisfaction with Outcome" scores between groups

  an average of 1 year following surgery

Study Arms (2)

Office-based limited facelift

EXPERIMENTAL

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

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

Hospital-based full facelift

ACTIVE COMPARATOR

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

Procedure: Full 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

Interventions

Limited facelift PROCEDURE

A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck

Also known as: Limited dissection SMAS manipulation

Office-based limited facelift

Full facelift PROCEDURE

A full face and neck lift that addresses signs of aging in the face and neck

Also known as: SMAS manipulation

Hospital-based full facelift

FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline OTHER

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.

Hospital-based full facelift; Office-based limited facelift

FACE-Q | Aesthetics - Recovery Early Symptoms OTHER

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.

Hospital-based full facelift; Office-based limited facelift

FACE-Q | Aesthetics - Satisfaction with Outcome OTHER

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.

Hospital-based full facelift; Office-based limited facelift

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

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; Office-based limited facelift

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dufresne, Craig, MD, PC: lead

Study Sites (1)

Office of Craig R Dufresne, MD, PC

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Facial Asymmetry

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig R Dufresne, MD

  Office of Dr Craig R Dufresne, MD, PC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikaela I Poling, BA

CONTACT

7032073065; research@duplastics.com

Craig R Dufresne, MD

CONTACT

7032073065; info@duplastics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 15, 2022
• Study Start: June 30, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)