Level B· Emerging clinical evidence with positive signalsClinical TrialPubMed

Changing the Paradigm of Craniofacial Reconstruction: A Prospective Clinical Trial of Autologous Fat Transfer for Craniofacial Deformities.

Bourne DA., Bliley J., James I., Donnenberg AD., Donnenberg VS., Branstetter BF.

Clinical Trial with a reported sample of 20 on Face & Skin, Hip, published in Ann Surg (2021) — summary generated from the PubMed abstract.

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Level B· Emerging clinical evidence with positive signalsEvidence level of this study

Several human studies show positive signals, while research methods and sample sizes continue to develop.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
Read the A–D evidence level guide

This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Clinical Trial
Journal
Ann Surg (2021)
Country
United States
Reported sample size
20
Source database
PubMed
PMID
30985369
PMCID
PMC11537244
DOI
10.1097/SLA.0000000000003318
NCT
NCT02267187
Citations
18

Abstract (original English)

This study aimed to prospectively assess outcomes for surgical autologous fat transfer (AFT) applied for traumatic and postsurgical craniofacial deformities. The minimally invasive nature of AFT has potential for reduced risk and superior outcomes compared with current reconstructive options. Craniofacial deformities have functional and psychosocial sequelae and can profoundly affect quality of life. Traditional reconstructive options are invasive, invasive, complex, and often lack precision in outcomes. Although AFT is safe, effective, and minimally invasive, only anecdotal evidence exists for reconstruction of craniofacial deformities. In this Institutional Review Board-approved prospective cohort study, 20 subjects underwent AFT (average volume: 23.9 ± 13.2 mL). Volume retention over time was determined using high-resolution computed tomography. Flow cytometry was used to assess cellular subpopulations and viability in the stromal vascular fraction. Quality of life assessments were performed. After the completion of 9-month follow-up, 5 subjects were enrolled for a second treatment. No serious adverse events occurred. Volume retention averaged 63 ± 17% at 9 months. Three-month retention strongly predicted 9-month retention (r=0.996, P < 0.0001). There was no correlation between the total volume injected and retention. Patients undergoing a second procedure had similar volume

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

How we grade evidence
Adipose TissueAdultCraniofacial AbnormalitiesFemaleFollow-Up StudiesGraft SurvivalHumansMaleMiddle AgedPatient Reported Outcome Measures

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