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Prospective Agreement Study of Magnetic Resonance Imaging Measurements and Intraoperative Dimensions During Gluteal Permanent Synthetic Filler Removal
Sponsor: Research Inc
Summary
This prospective agreement study will compare preoperative MRI measurements with direct surgical measurements in adults undergoing removal of gluteal tissue affected by permanent synthetic fillers. MRI will estimate affected-tissue dimensions and residual skin-flap thickness at predefined landmarks. During surgery, the same flap landmarks and the fresh excised specimen will be measured. The primary outcome is agreement between MRI and intraoperative flap thickness; postoperative ischemia, wound dehiscence, and necrosis will be followed through 30 days.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
220
Start Date
2026-10-01
Completion Date
2027-12-01
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
Preoperative MRI Morphometric Mapping
Three orthogonal dimensions of the affected block and residual flap thickness at fixed surface landmarks will be measured on MRI by two trained readers. Affected-tissue volume will be estimated using segmentation when available and a prespecified geometric approximation otherwise. Linked arm/group(s): MRI-to-Surgery Agreement Cohort.
Standardized Intraoperative and Fresh-Specimen Measurement
Before closure, residual flap thickness will be measured with a calibrated sterile device at the same mapped landmarks without compressing the tissue. The fresh excised block will be oriented and measured in three axes before fixation. Specimen weight will also be recorded. Linked arm/group(s): MRI-to-Surgery Agreement Cohort.