Status: Not yet recruiting
Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
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.
Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Research IncUpdated: Sep 9, 2026Locations: 1Duration: 1 Year
Eligibility criteria
Prior gluteal injection of a permanent or unknown nonresorbable filler. [+3]
Specimen composed only of scar or skin without tissue from the filler-affected r... [+4]