Clinical trial NCT03286231: Anti-FLEX: Flexed Levering of Gluteal Vessels
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: gluteal venous vasculature
prone position
jackknife position
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 11
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean difference of position of the gluteal venous vasculature in relation to the skin
timeFrame: at CT scan visit
Secondary outcomes:
measure: Mean difference of vessel diameter of the gluteal venous vasculature
timeFrame: at CT scan visit
measure: Mean difference of the danger zone
timeFrame: at CT scan visit
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Connor Barnes, MD
role: PRINCIPAL_INVESTIGATOR
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