Anti-FLEX: Flexed Levering of Gluteal Vessels

NCT03286231 | Completed

• 1 other identifier: Pro00031729
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

gluteal venous vasculature; prone position; jackknife position

Outcome Measures

Primary Outcomes (1)

• Mean difference of position of the gluteal venous vasculature in relation to the skin

  Between the Prone position and the Jackknife position

  at CT scan visit

Secondary Outcomes (2)

• Mean difference of vessel diameter of the gluteal venous vasculature

  at CT scan visit

• Mean difference of the danger zone

  at CT scan visit

Study Arms (1)

Healthy volunteers

Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions

Diagnostic Test: CT imaging

Interventions

CT imaging DIAGNOSTIC_TEST

Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions

Healthy volunteers

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Females only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers who will undergo contrast-enhanced CT imaging of the gluteal venous vasculature in the prone and jackknife positions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

Postmortem Imaging

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Connor Barnes, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: May 3, 2018
• Primary Completion: November 21, 2018
• Study Completion: January 13, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)