Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
7. september 2026 oppdatert av: Research Inc
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Edison Osorio, MD, Plastic surgeon
- Telefonnummer: +573226140611
- E-post: info@edisonosorio.com
Studiesteder
-
-
Antioquia
-
Medellín, Antioquia, Colombia
- Clinica Bioforma
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Ta kontakt med:
- Edison Osorio, MD, Plastic surgeon
- Telefonnummer: +573226140611
- E-post: info@edisonosorio.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
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.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite Histopathologic Severity Score by Clinical-Radiologic Stage
Tidsramme: 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.
|
At the index operation and final blinded histopathology assessment of the surgical specimen. 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of Individual Histopathologic Features
Tidsramme: 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.
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At final histopathology assessment of the index surgical specimen. 3 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Histopathologic Phenotype Classification
Tidsramme: After completion of tissue collection and database lock, using data from the index specimen. 1 year
|
Data-driven clusters or latent classes based on the eight domains, integrated with clinical and MRI stage to generate a proposed disease-evolution framework.
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After completion of tissue collection and database lock, using data from the index specimen. 1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Edison Osorio, MD, plastic surgery
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. desember 2027
Studiet fullført (Antatt)
1. desember 2027
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
7. september 2026
Først lagt ut (Faktiske)
9. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 009 (Nahrain Medical Research Collective (NMRC))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
not considered in the informed consent of the patients
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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