Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07805889

Ultrasound-Assessed Facial Macrofat Retention After Facelift

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NS Plastic surgery

Barranquilla, Colombia

Location status: Recruiting

Location contact

Nora Stanford, MD, Plastic surgeon

CONTACT

[email protected]

+57 311 4146505

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Facelift plus facial fat grafting

Procedure

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

Primary outcomes

  1. Percentage Retention of Ultrasound-Derived Facial Graft Volume

    Time frame: 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 outcomes

  1. Ultrasound-Defined Subcutaneous Tissue Remodeling Score

    Time frame: 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.

  2. Incidence of Fat-Grafting-Related Complications

    Time frame: 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.

  3. Change in FACE-Q Facial Appearance Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nora Stanford, MD, Plastic surgeon

CONTACT

[email protected]

+57 311 4146505

Sponsors and collaborators

Lead sponsor

Research Inc

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.