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Anti-FLEX: Flexed Levering of Gluteal Vessels

NCT03286231 — Completed, 11 participants, University of South Florida
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Anti-FLEX: Flexed Levering of Gluteal Vessels on OR Table May Lead to Extreme Danger During Gluteal Augmentation With Lipoaspirate, a Radio-graphically Studied Position of Superior and Inferior Gluteal Vessels During Flexion of OR Table or "Jack-knife" Position, Danger Zone.

RegistryNCT03286231
StatusCompleted
Study typeObservational
Enrollment11 (Actual)
SponsorUniversity of South Florida (Other)
ConditionsHealthy
InterventionsCT imaging (Diagnostic test)
Datesstart 2018-05-03, primary completion 2018-11-21, completion 2020-01-13, first posted 2017-09-18, last updated 2020-02-28
Locations1 site in United States

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-Summary

The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone and jackknife positions.

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+Detailed description

This is a prospective collection of contrast-enhanced CT images of healthy female volunteers in prone and jackknife positions in order to determine if position impacts gluteal venous vasculature.

+Arms and interventions

ArmTypeInterventionsDescription
Healthy volunteersDiagnostic Test: CT imagingHealthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions
  • CT imaging (Diagnostic test): Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions

+Outcome measures

Primary outcomes

  • Mean difference of position of the gluteal venous vasculature in relation to the skin [at CT scan visit]: Between the Prone position and the Jackknife position

Secondary outcomes

  • Mean difference of vessel diameter of the gluteal venous vasculature [at CT scan visit]: Between the Prone position and the Jackknife position
  • Mean difference of the danger zone [at CT scan visit]: Between the Prone position and the Jackknife position

+Eligibility

Sex: Female, ages: 20 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* Females age 20 - 50 years
* BMI between 20 - 35 kg/m2
* Willingness and ability to provide written informed consent
* Willingness and ability to comply with all study procedures
* Interested or planning to have a gluteal augmentation

Exclusion Criteria:

* Males
* Females age < 20 or >= 51 years
* BMI between < 20 or > 35 kg/m2
* Prior gluteal augmentation surgery
* Any prior gluteal soft tissue filler
* Known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium
* Documented history of chronic kidney disease that contraindicates the use of contrast dye
* Pregnant
* Currently breast-feeding
* Any reason (in addition to those listed above) that, in the opinion of the principal investigator, precludes full participation in the study

+Locations (1)

FacilityCityCountryStatus
Tampa General HospitalTampa, FloridaUnited States

+Publications

  • Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available. PMID 3725947
  • Hsu VM, Stransky CA, Bucky LP, Percec I. Fat grafting's past, present, and future: why adipose tissue is emerging as a critical link to the advancement of regenerative medicine. Aesthet Surg J. 2012 Sep;32(7):892-9. doi: 10.1177/1090820X12455658. PMID 22942117
  • Cardenas-Camarena L, Arenas-Quintana R, Robles-Cervantes JA. Buttocks fat grafting: 14 years of evolution and experience. Plast Reconstr Surg. 2011 Aug;128(2):545-555. doi: 10.1097/PRS.0b013e31821b640b. PMID 21788847
  • Toledo LS. Gluteal augmentation with fat grafting: the Brazilian buttock technique: 30 years' experience. Clin Plast Surg. 2015 Apr;42(2):253-61. doi: 10.1016/j.cps.2014.12.004. PMID 25827567
  • LINCOLN JR, SAWYER HP Jr. Complications related to body positions during surgical procedures. Anesthesiology. 1961 Sep-Oct;22:800-9. doi: 10.1097/00000542-196109000-00014. No abstract available. PMID 14465376
  • Astarita DC, Scheinin LA, Sathyavagiswaran L. Fat transfer and fatal macroembolization. J Forensic Sci. 2015 Mar;60(2):509-10. doi: 10.1111/1556-4029.12549. Epub 2015 Feb 4. PMID 25653075
  • Results publication: Mofid MM, Teitelbaum S, Suissa D, Ramirez-Montanana A, Astarita DC, Mendieta C, Singer R. Report on Mortality from Gluteal Fat Grafting: Recommendations from the ASERF Task Force. Aesthet Surg J. 2017 Jul 1;37(7):796-806. doi: 10.1093/asj/sjx004. PMID 28369293
  • Results publication: Klein SM, Prantl L, Geis S, Eisenmann-Klein M, Dolderer J, Felthaus O, Loibl M, Heine N. Pressure monitoring during lipofilling procedures. Clin Hemorheol Microcirc. 2014;58(1):9-17. doi: 10.3233/CH-141872. PMID 25227189
  • Results publication: Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107. PMID 2343107

+Investigators

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