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Ultrasound-Assessed Facial Macrofat Retention After Facelift

Ultrasound-Assessed Facial Macrofat Retention After Facelift

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07805889
Enrollment
400
Registered
2026-09-08
Start date
2023-01-01
Completion date
2027-03-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facelift Surgery, Fat Grafting

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

PROCEDUREFacelift plus facial fat grafting

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

Research Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Percentage Retention of Ultrasound-Derived Facial Graft VolumePostoperative 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

MeasureTime frameDescription
Ultrasound-Defined Subcutaneous Tissue Remodeling ScoreBaseline, 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 ComplicationsFrom 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 ScoreBaseline 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

Contacts

CONTACTNora Stanford, MD, Plastic surgeon
info@dranorastanford.com+57 311 4146505
PRINCIPAL_INVESTIGATORNORA STANFORD, MD, plastic surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026