Anti-FLEX: Flexed Levering of Gluteal Vessels

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: CT imaging

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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference of vessel diameter of the gluteal venous vasculature	Between the Prone position and the Jackknife position	at CT scan visit
Mean difference of the danger zone	Between the Prone position and the Jackknife position	at CT scan visit

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Connor Barnes, MD, University of South Florida

Publications and helpful links

General Publications

• 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.
• Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: prone position; gluteal venous vasculature; jackknife position
• Other Study ID Numbers: Pro00031729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No