Facelift Surgery, Fat Grafting
Conditions
Keywords
facelift, fat grafting, ultrasound, outcomes, patient satisfaction
Brief summary
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.
Detailed description
Research question Among adults undergoing facelift with standardized facial macrofat grafting, what proportion of the ultrasound-derived grafted tissue volume is retained at 12 months, and what structural changes occur in the facial subcutaneous tissue? Primary hypothesis Ultrasound-derived grafted tissue volume will show measurable persistence at 12 months, with stable or improved subcutaneous tissue thickness and organization and an acceptable rate of fat-grafting-related complications. Primary objective To estimate the percentage retention of ultrasound-derived facial graft volume at 12 months relative to the postoperative month-1 reference assessment. Secondary objectives * To quantify zone-specific changes in facial subcutaneous thickness, echogenicity, homogeneity, and vascularity. * To evaluate the association between injected macrofat volume and retained ultrasound-derived volume. * To document fat-grafting-related adverse events, including clinically significant nodules, cysts, infection, contour irregularity, and need for revision. * To measure patient-reported satisfaction with facial appearance using selected FACE-Q scales, subject to licensing and final scale selection.
Interventions
Facelift 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
Sponsors
Study design
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Pregnancy or breastfeeding at enrollment. * Inability to obtain technically adequate baseline ultrasound measurements in the predefined facial zones.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Retention of Ultrasound-Derived Facial Graft Volume | Postoperative month 1 and postoperative month 12. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound-Defined Subcutaneous Tissue Remodeling Score | Baseline, postoperative month 1, and postoperative month 12. | 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. |
| Incidence of Fat-Grafting-Related Complications | From surgery through postoperative month 12. | 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. |
| Change in FACE-Q Facial Appearance Score | Baseline and postoperative month 12. | 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. |
Countries
Colombia