Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications

NCT07808970 | Not Yet Recruiting

• 1 other identifier: 009
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Foreign-Body Reaction; Granulomatous Disease; Soft Tissue Necrosis Lower Limb; Gluteal Permanent Synthetic Filler Disease

Keywords

Biopolymers; Histopathology; Foreign-Body Granuloma; Fibrosis; Fat Necrosis; Disease Staging; Natural History

Outcome Measures

Primary Outcomes (1)

• Composite Histopathologic Severity Score by Clinical-Radiologic Stage

  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.

  At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months

Secondary Outcomes (1)

• Prevalence of Individual Histopathologic Features

  At final histopathology assessment of the index surgical specimen. 3 months

Other Outcomes (1)

• Histopathologic Phenotype Classification

  After completion of tissue collection and database lock, using data from the index specimen. 1 year

Study Arms (1)

Prospective Histopathology Cohort

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.

Procedure: Standardized Tissue Sampling During Clinically Indicated Surgery; Other: Blinded Histopathologic Scoring

Interventions

Standardized Tissue Sampling During Clinically Indicated Surgery PROCEDURE

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.

Prospective Histopathology Cohort

Blinded Histopathologic Scoring OTHER

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.

Prospective Histopathology Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Inc: lead

Study Sites (1)

Clinica Bioforma

Medellín, Antioquia, Colombia

Location

Related Publications (4)

• Pachon Suarez JE, Tello VZR, Cifuentes RCR, Cuadros AMP, Salazar MC. Biopolymers: Histopathologic Case Series of Patients with Permanent Synthetic Fillers Presenting Chronic Granulomatous Reaction and Hypercalcemia. Plast Reconstr Surg Glob Open. 2024 Oct 15;12(10):e6159. doi: 10.1097/GOX.0000000000006159. eCollection 2024 Oct.

  PMID: 39410973 BACKGROUND

• Pachon Suarez JE, Salazar MC, Rizo VZ. Classification for Staging and Managing Patients with Biopolymer-induced Human Adjuvant Disease. Plast Reconstr Surg Glob Open. 2022 Feb 24;10(2):e4137. doi: 10.1097/GOX.0000000000004137. eCollection 2022 Feb.

  PMID: 35233337 BACKGROUND

• Xu T, Zhang J, Zhu Y, Zhao W, Pan C, Ma H, Zhang L. A poly(hydroxyethyl methacrylate)-Ag nanoparticle porous hydrogel for simultaneous in vivo prevention of the foreign-body reaction and bacterial infection. Nanotechnology. 2018 Sep 28;29(39):395101. doi: 10.1088/1361-6528/aad257. Epub 2018 Jul 10.

  PMID: 29989569 BACKGROUND

• Osorio E, Ramirez B, Herrera O, Suarez C, Ciro C, Varela A. Three-flap Technique: Comprehensive Approach for Biopolymer Removal in the Gluteal and Lumbar Regions. Plast Reconstr Surg Glob Open. 2026 Jul 23;14(7):e7870. doi: 10.1097/GOX.0000000000007870. eCollection 2026 Jul.

  PMID: 42495057 BACKGROUND

MeSH Terms

Conditions

Foreign-Body Reaction; Granuloma, Foreign-Body; Fibrosis; Fat Necrosis

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foreign Bodies; Wounds and Injuries; Granuloma; Necrosis

Study Officials

• Edison Osorio, MD, plastic surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edison Osorio, MD, Plastic surgeon

CONTACT

+573226140611; info@edisonosorio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)