Ultrasound-Assessed Facial Macrofat Retention After Facelift

September 1, 2026 updated by: Research Inc
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
      • Barranquilla, Colombia
        • Recruiting
        • NS Plastic surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing elective facelift surgery for facial aging in whom autologous facial macrofat grafting is planned as part of the operative protocol.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative month 1 and postoperative month 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, postoperative month 1, and postoperative month 12.
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.
From surgery through postoperative month 12.
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.
Baseline and postoperative month 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Inc

Investigators

  • Principal Investigator: NORA STANFORD, MD, plastic surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 1, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 8, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is a research just leaded by one surgeon, and er are not interested to do it with otherones

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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