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

NCT ID: NCT05419609

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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Skin Aging Facial Asymmetry Aging Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Limited facelift

Intervention Type PROCEDURE

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

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

Intervention Type 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.

FACE-Q | Aesthetics - Recovery Early Symptoms

Intervention Type 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.

FACE-Q | Aesthetics - Satisfaction with Outcome

Intervention Type 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.

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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Full facelift

Intervention Type PROCEDURE

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

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

Intervention Type 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.

FACE-Q | Aesthetics - Recovery Early Symptoms

Intervention Type 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.

FACE-Q | Aesthetics - Satisfaction with Outcome

Intervention Type 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.

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

Intervention Type 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.

Interventions

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Limited facelift

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

Intervention Type PROCEDURE

Full facelift

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

Intervention Type PROCEDURE

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Limited dissection SMAS manipulation SMAS manipulation

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dufresne, Craig, MD, PC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig R Dufresne, MD

Role: PRINCIPAL_INVESTIGATOR

Office of Dr Craig R Dufresne, MD, PC

Locations

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Office of Craig R Dufresne, MD, PC

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mikaela I Poling, BA

Role: CONTACT

7032073065

Craig R Dufresne, MD

Role: CONTACT

7032073065

Facility Contacts

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Craig R Dufresne, MD

Role: primary

703-207-3065

Mikaela I Poling, BA

Role: backup

703-207-3065

Other Identifiers

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U1111-1278-8245

Identifier Type: -

Identifier Source: org_study_id

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