Foreign-Body Reaction, Gluteal Permanent Synthetic Filler Disease, Granulomatous Disease, Soft Tissue Necrosis Lower Limb
Conditions
Keywords
Biopolymers, Histopathology, Foreign-Body Granuloma, Fibrosis, Fat Necrosis, Disease Staging, Natural History
Brief 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.
Detailed description
Participants will be enrolled before clinically indicated biopsy or filler-removal surgery. Exposure history, symptoms, physical findings, and MRI stage will be recorded using standardized forms. During surgery, samples from mapped tissue planes will be collected without extending the planned excision. Two pathologists blinded to clinical stage will independently grade eight tissue-injury domains and generate a composite severity score. Disagreements will undergo adjudication. The study will evaluate associations between tissue findings, time since injection, and clinical-radiologic stage and will use exploratory clustering to identify histopathologic phenotypes. Because participants are sampled at one operation, the resulting model will be described as a proposed cross-sectional natural-history framework.
Interventions
PROCEDUREStandardized 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.
OTHERBlinded 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.
Sponsors
Research Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years or older. * Prior gluteal injection of a permanent or unknown nonresorbable filler. * Clinically indicated biopsy or surgical excision yielding tissue suitable for histopathologic evaluation. * Available history of approximate injection date and standardized preoperative clinical staging. * Written consent for tissue analysis and optional future use of deidentified specimens.
Exclusion criteria
* Specimen composed only of scar or skin without tissue from the filler-affected region. * Insufficient tissue quality for routine histology. * Acute bacterial infection that precludes distinction of the underlying chronic tissue response unless infection is itself a prespecified advanced-stage feature. * Prior oncologic radiation to the sampled gluteal region. * Declined consent for research use of surgical tissue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Histopathologic Severity Score by Clinical-Radiologic Stage | At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months | Sum of eight prespecified 0-to-3 domain scores: foreign material burden, granulomatous inflammation, fibrosis, fat necrosis, vascular injury, lymphatic involvement, muscle injury, and skin necrosis. Total score ranges from 0 to 24; higher scores indicate more severe tissue injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Individual Histopathologic Features | At final histopathology assessment of the index surgical specimen. 3 months | Proportion of participants with each prespecified feature and distribution of each 0-to-3 domain grade. |
Countries
Colombia
Contacts
CONTACTEdison Osorio, MD, Plastic surgeon
PRINCIPAL_INVESTIGATOREdison Osorio, MD, plastic surgery
Outcome results
None listed