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RecruitingNCT07805889Updated Sep 8, 2026

Ultrasound-Assessed Facial Macrofat Retention After Facelift

An observational study in Facelift Surgery and Fat Grafting, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Research Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Facelift Surgery
  • Fat Grafting

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Keywords

  • facelift
  • fat grafting
  • ultrasound
  • outcomes
  • patient satisfaction
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

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

05

What researchers measure

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.

06

Study locations

1 of 1 sites recruiting
  • NS Plastic surgery
    Barranquilla, Colombia
    Recruiting
07

References and documents

Publications

  • Dhooghe NS, Maes S, Depypere B, Claes KEY, Coopman R, Kubat B, Piette MH, Monstrey S. Fat Embolism After Autologous Facial Fat Grafting. Aesthet Surg J. 2022 Feb 15;42(3):231-238. doi: 10.1093/asj/sjab252. PubMed 34133713 ↗
  • Jerliu A, Watters A, Harrison L, Hughes CD, Babigian A, Castiglione C. Fat Necrosis After Facial Autologous Fat Grafting: A Systematic Review of Reported Complications and Management Strategies. Aesthetic Plast Surg. 2026 Jul 9. doi: 10.1007/s00266-026-06047-z. Online ahead of print. PubMed 42423965 ↗
  • Kaur S, Rubin JP, Gusenoff J, Sommers CA, Shamsunder MG, Hume KM, Mehrara BJ. The General Registry of Autologous Fat Transfer: Concept, Design, and Analysis of Fat Grafting Complications. Plast Reconstr Surg. 2022 Jun 1;149(6):1118e-1129e. doi: 10.1097/PRS.0000000000009162. Epub 2022 Apr 11. PubMed 35404336 ↗
  • Schiraldi L, Sapino G, Meuli J, Maruccia M, Cherubino M, Raffoul W, di Summa PG. Facial Fat Grafting (FFG): Worth the Risk? A Systematic Review of Complications and Critical Appraisal. J Clin Med. 2022 Aug 11;11(16):4708. doi: 10.3390/jcm11164708. PubMed 36012947 ↗
  • van Dongen JA, Langeveld M, van de Lande LS, Harmsen MC, Stevens HP, van der Lei B. The Effects of Facial Lipografting on Skin Quality: A Systematic Review. Plast Reconstr Surg. 2019 Nov;144(5):784e-797e. doi: 10.1097/PRS.0000000000006147. PubMed 31688753 ↗
  • Ma X, Huang J, Long X, Wang X. Quantifying outcomes of autologous fat transplantation in different facial deformities: A systemic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2023 Dec;87:117-130. doi: 10.1016/j.bjps.2023.09.007. Epub 2023 Sep 12. PubMed 37837945 ↗
  • Strong AL, Rohrich RJ, Tonnard PL, Vargo JD, Cederna PS. Technical Precision with Autologous Fat Grafting for Facial Rejuvenation: A Review of the Evolving Science. Plast Reconstr Surg. 2024 Feb 1;153(2):360-377. doi: 10.1097/PRS.0000000000010643. Epub 2023 May 9. PubMed 37159906 ↗
  • Xiong S, Yi C, Pu LLQ. An Overview of Principles and New Techniques for Facial Fat Grafting. Clin Plast Surg. 2020 Jan;47(1):7-17. doi: 10.1016/j.cps.2019.08.001. Epub 2019 Oct 21. PubMed 31739899 ↗

Individual participant data

Plan to share: No — It is a research just leaded by one surgeon, and er are not interested to do it with otherones

08

Registry details

Key details

Study ID
NCT07805889
Lead sponsor
Research Inc
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Jan 1, 2023
Primary completion
Dec 10, 2026 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Nora Stanford, MD, Plastic surgeon
Contact
info@dranorastanford.com
+57 311 4146505
NORA STANFORD, MD, plastic surgery
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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