Facelift SurgeryNCT07805889
Ultrasound-Assessed Facial Macrofat Retention After Facelift
An observational study of Facelift Surgery and Fat Grafting, run by Research Inc at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Facelift Surgery, Fat Grafting
- What is being tested?
- Facelift plus facial fat grafting
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2023to 1 Mar 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing elective facelift surgery for facial aging in whom autologous facial macrofat grafting is planned as part of the operative protocol.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
NS Plastic surgery
Barranquilla
Nora Stanford, MD, Plastic surgeon, +57 311 4146505, info@dranorastanford.com
About this study
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.
- Conditions
- Facelift Surgery, Fat Grafting
- Being tested
- Facelift plus facial fat grafting
- Keywords
- facelift, fat grafting, ultrasound, outcomes, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facelift plus facial fat graftingProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative month 1 and postoperative month 12.
Secondary outcomes (3)
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.
Measured: Baseline, postoperative month 1, and postoperative month 12.
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.
Measured: From surgery through postoperative month 12.
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.
Measured: Baseline and postoperative month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jan 2023
- Primary completion10 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Facelift SurgeryStudies of the same condition, open and under way.
- More trials run by Research IncThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- NORA STANFORD, MD, plastic surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805889
- Sponsor's protocol ID
- 005
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is a research just leaded by one surgeon, and er are not interested to do it with otherones
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 34133713Jerliu 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 42423965Kaur 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 35404336Schiraldi 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 36012947van 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 31688753Ma 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 37837945Strong 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 37159906Xiong 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Assessed Facial Macrofat Retention After Facelift
- ClinicalTrials.gov ID
- NCT07805889
- Acronym / sponsor ID
- 005
- Conditions
- Facelift Surgery, Fat Grafting
- Keywords
- facelift, fat grafting, ultrasound, outcomes, patient satisfaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective facelift surgery for facial aging in whom autologous facial macrofat grafting is planned as part of the operative protocol.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facelift plus facial fat graftingFacelift 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 | Procedure or surgery | – |
Primary outcome
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.
3 secondary outcomes
Ultrasound-Defined Subcutaneous Tissue Remodeling Score
Time frame: Baseline, postoperative month 1, and postoperative month 12.
Incidence of Fat-Grafting-Related Complications
Time frame: From surgery through postoperative month 12.
Change in FACE-Q Facial Appearance Score
Time frame: Baseline and postoperative month 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 34133713Dhooghe 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.
- Background: PubMed 42423965Jerliu 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.
- Background: PubMed 35404336Kaur 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.
- Background: PubMed 36012947Schiraldi 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.
- Background: PubMed 31688753van 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.
- Background: PubMed 37837945Ma 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.
- Background: PubMed 37159906Strong 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.
- Background: PubMed 31739899Xiong 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.
- Individual participant dataSharing planned: No. It is a research just leaded by one surgeon, and er are not interested to do it with otherones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NORA STANFORD, MD, plastic surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facelift Surgery and Fat Grafting, run by Research Inc at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Stanford, MD, Plastic surgeon (+57 311 4146505, info@dranorastanford.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Retention of Ultrasound-Derived Facial Graft Volume (time frame: Postoperative month 1 and postoperative month 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805889, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.