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Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
Sponsor: Research Inc
Summary
This prospective biospecimen cohort will collect and analyze tissue from adults undergoing clinically indicated surgery for gluteal permanent synthetic filler disease. Two blinded pathologists will score foreign material burden, inflammation, fibrosis, necrosis, vascular and lymphatic injury, and deep-tissue involvement. Histopathologic severity will be compared across clinical-radiologic stages and time since injection. The study will propose a cross-sectional disease-evolution framework and assess the reproducibility of the scoring system.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-10-01
Completion Date
2027-12-01
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
Standardized Tissue Sampling During Clinically Indicated Surgery
Samples will be obtained from predefined superficial, interface, deep, and visibly abnormal regions without extending the clinically indicated excision. Each sample will be oriented and linked to an MRI/operative map. Linked arm/group(s): Prospective Histopathology Cohort.
Blinded Histopathologic Scoring
Two pathologists will independently grade foreign material burden, granulomatous inflammation, fibrosis, fat necrosis, vascular injury, lymphatic involvement, muscle injury, and skin necrosis on 0-to-3 ordinal scales. The proposed composite ranges from 0 to 24; the manual will be locked before the first analytic read. Linked arm/group(s): Prospective Histopathology Cohort.
Locations (1)
Clinica Bioforma
Medellín, Antioquia, Colombia