Back to resultsComparison of an Office-based Limited Facelift and Hospital-based Full Facelift (COAL2)
Primary Purpose
Skin Aging, Facial Asymmetry, Aging Problems
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Limited facelift
Full facelift
FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline
FACE-Q | Aesthetics - Recovery Early Symptoms
FACE-Q | Aesthetics - Satisfaction with Outcome
FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck
Sponsored by
About this trial
This is an interventional treatment trial for Skin Aging focused on measuring Rhytidoplasty, Facelift, Rhytidectomy, Superficial Musculoaponeurotic System
Eligibility Criteria
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
Sites / Locations
- Office of Craig R Dufresne, MD, PCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Office-based limited facelift
Hospital-based full facelift
Arm Description
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05419609
Brief Title
Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dufresne, Craig, MD, PC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Aging, Facial Asymmetry, Aging Problems
Keywords
Rhytidoplasty, Facelift, Rhytidectomy, Superficial Musculoaponeurotic System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Office-based limited facelift
Arm Type
Experimental
Arm Description
Patients will undergo a limited facelift in the office. Patients will receive local anesthesia and optionally may receive an antianxiety medication.
Arm Title
Hospital-based full facelift
Arm Type
Active Comparator
Arm Description
Patients will undergo a full facelift in the hospital or ambulatory surgical center. Patients will receive either general anesthesia or intravenous sedation.
Intervention Type
Procedure
Intervention Name(s)
Limited facelift
Other Intervention Name(s)
Limited dissection SMAS manipulation
Intervention Description
A limited procedure under local anesthesia that addresses signs of aging in the lower face and neck
Intervention Type
Procedure
Intervention Name(s)
Full facelift
Other Intervention Name(s)
SMAS manipulation
Intervention Description
A full face and neck lift that addresses signs of aging in the face and neck
Intervention Type
Other
Intervention Name(s)
FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline
Intervention Description
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
Intervention Name(s)
FACE-Q | Aesthetics - Recovery Early Symptoms
Intervention Description
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
Intervention Name(s)
FACE-Q | Aesthetics - Satisfaction with Outcome
Intervention Description
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
Intervention Name(s)
FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference between groups in number of patients requiring treatment by surgeon for post-operative adverse effects
Description
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.
Time Frame
1 hour following surgery and 2 weeks following surgery
Title
Difference in post-operative aesthetic correction rating between groups
Description
Post-operative aesthetic correction rating is completed based on comparison with pre-operative photographs. Ratings possible are 1 (no improvement) to 5 (excellent).
Time Frame
an average of 1 year following surgery
Secondary Outcome Measure Information:
Title
Change in score of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" from baseline to last post-operative visit
Description
The "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" is a validated patient satisfaction survey for the lower face and jawline.
Time Frame
an average of 30 days before surgery and again an average of 1 year following surgery
Other Pre-specified Outcome Measures:
Title
Difference of "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" baseline and last post-operative visit scores between groups
Description
The "FACE-Q | Aesthetics - Satisfaction With Lower Face and Jawline" is a validated patient satisfaction survey for the lower face and jawline.
Time Frame
an average of 30 days before surgery and again an average of 1 year following surgery
Title
Difference of "FACE-Q - Recovery Early Symptoms" scores between groups
Description
The "FACE-Q - Recovery Early Symptoms" is a validated patient satisfaction survey for the early post-operative period following aesthetic facial procedures.
Time Frame
1 week following surgery
Title
Difference of "FACE-Q | Aesthetics - Satisfaction with Outcome" scores between groups
Description
The "FACE-Q | Aesthetics - Satisfaction with Outcome" is a validated patient satisfaction survey for final outcomes following aesthetic facial procedures.
Time Frame
an average of 1 year following surgery
Title
Difference of "FACE-Q | Aesthetics - Adverse Effects: Cheeks, Lower Face, Neck" scores between groups
Description
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.
Time Frame
an average of 1 year following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikaela I Poling, BA
Phone
7032073065
Email
research@duplastics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Craig R Dufresne, MD
Phone
7032073065
Email
info@duplastics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig R Dufresne, MD
Organizational Affiliation
Office of Dr Craig R Dufresne, MD, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Office of Craig R Dufresne, MD, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig R Dufresne, MD
Phone
703-207-3065
Email
info@duplastics.com
First Name & Middle Initial & Last Name & Degree
Mikaela I Poling, BA
Phone
703-207-3065
Email
research@duplastics.com
First Name & Middle Initial & Last Name & Degree
Craig R Dufresne, MD
First Name & Middle Initial & Last Name & Degree
Mikaela I Poling, BA
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data (IPD) will not be available to other researchers.
Learn more about this trial
Comparison of an Office-based Limited Facelift and Hospital-based Full Facelift
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