Ultrasound-Assessed Facial Macrofat Retention After Facelift

NCT07805889 | Recruiting

• 1 other identifier: 005
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Facelift Surgery; Fat Grafting

Keywords

facelift; fat grafting; ultrasound; outcomes; patient satisfaction

Outcome Measures

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.

  Postoperative month 1 and postoperative month 12.

Secondary Outcomes (3)

• Ultrasound-Defined Subcutaneous Tissue Remodeling Score

  Baseline, postoperative month 1, and postoperative month 12.

• Incidence of Fat-Grafting-Related Complications

  From surgery through postoperative month 12.

• Change in FACE-Q Facial Appearance Score

  Baseline and postoperative month 12.

Interventions

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

NS Plastic surgery

Barranquilla, Colombia

RECRUITING

Related Publications (8)

• 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.

  PMID: 34133713 BACKGROUND

• 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.

  PMID: 42423965 BACKGROUND

• 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.

  PMID: 35404336 BACKGROUND

• 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.

  PMID: 36012947 BACKGROUND

• 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.

  PMID: 31688753 BACKGROUND

• 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.

  PMID: 37837945 BACKGROUND

• 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.

  PMID: 37159906 BACKGROUND

• 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.

  PMID: 31739899 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Rhytidoplasty

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• NORA STANFORD, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Stanford, MD, Plastic surgeon

CONTACT

+57 311 4146505; info@dranorastanford.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)