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

Last updated: July 15, 2022
Sponsor: Dufresne, Craig, MD, PC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Aging

Treatment

N/A

Clinical Study ID

NCT05419609
U1111-1278-8245
  • Ages 40-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient willing to randomly undergo either a limited facelift done in the office or afull facelift done in the hospital
  • Patient willing and able to accept financial responsibilities of undergoing eithertype 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 faceliftdone in the office or a full facelift done in the hospital

Exclusion

Exclusion Criteria:

  • Patient refusal to randomly undergo either a limited facelift done in the office or afull facelift done in the hospital
  • Patient not willing or not able to accept financial responsibilities of undergoingeither 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, heartdisease, etc.)
  • Uncontrolled hypertension
  • Surgeon believes patient could not tolerate or safely undergo either a limitedfacelift done in the office or a full facelift done in the hospital

Study Design

Total Participants: 100
Study Start date:
June 30, 2022
Estimated Completion Date:
July 31, 2023

Study 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.

Connect with a study center

  • Office of Craig R Dufresne, MD, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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