Ultrasound-Assessed Facial Macrofat Retention After Facelift
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorResearch Inc
About this trial
Facelift surgery repositions facial soft tissues but does not by itself restore all age-related volume loss. Autologous macrofat can be placed during the same operation to restore volume, yet the amount of grafted tissue that remains and the way the facial subcutaneous layer remodels are not routinely quantified. This study will prospectively standardize injected-volume recording and ultrasound mapping of predefined facial zones. A one-month scan, obtained after the early postoperative period, will serve as the imaging reference for the grafted tissue compartment, and a one-year scan will quantify persistent volume and tissue remodeling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 65 years.
Scheduled for elective facelift surgery with facial autologous macrofat grafting specified before enrollment.
Ability to undergo standardized facial ultrasound at baseline, postoperative month 1, and postoperative month 12.
Capacity to provide written informed consent and comply with follow-up visits.
Disqualifiers
Prior facial fat grafting within 24 months before enrollment.
Active facial infection, uncontrolled inflammatory skin disease, or open facial wound.
Known lipodystrophy or systemic disease expected to substantially alter facial fat distribution during follow-up.
Planned major weight-loss intervention or anticipated body-weight change greater than 10% during follow-up.
Trial population
Adults undergoing elective facelift surgery for facial aging in whom autologous facial macrofat grafting is planned as part of the operative protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Facelift plus facial fat grafting
Procedure/SurgeryFacelift surgery is performed using the surgeon's standardized technique. Harvested autologous fat is processed as macrofat and injected into predefined facial zones. The injected volume, cannula size, plane, number of passes, and volume per zone will be recorded
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Percentage Retention of Ultrasound-Derived Facial Graft Volume
For each predefined facial zone, ultrasound-derived grafted-tissue volume at 12 months will be divided by the corresponding volume at postoperative month 1 and multiplied by 100. A participant-level weighted mean will be calculated using the month-1 zone volumes as weights. Higher percentages indicate greater volume persistence.
Time frame
Postoperative month 1 and postoperative month 12.Secondary outcomes
1
Ultrasound-Defined Subcutaneous Tissue Remodeling Score
A prespecified structured ultrasound score will grade echogenicity, tissue homogeneity, vascularity, and focal cystic or nodular changes in each treated zone. The scoring manual and inter-reader training set will be finalized before enrollment.
Time frame
Baseline, postoperative month 1, and postoperative month 12.2
Incidence of Fat-Grafting-Related Complications
Proportion of participants with at least one clinically significant nodule, oil cyst, infection, contour irregularity requiring treatment, fat necrosis, vascular event, or revision attributed to facial fat grafting.
Time frame
From surgery through postoperative month 12.3
Change in FACE-Q Facial Appearance Score
Rasch-transformed 0-to-100 score from the selected licensed FACE-Q appearance scale; higher scores indicate greater satisfaction. The final scale name will be inserted after licensing confirmation.
Time frame
Baseline and postoperative month 12.Sponsors and contacts
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Source ClinicalTrials.gov