Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Composite Histopathologic Severity Score by Clinical-Radiologic Stage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standardized Tissue Sampling During Clinically Indicated Surgery (Procedure)
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.
干预措施: Blinded Histopathologic Scoring (Other)
结局指标
主要结局
Composite Histopathologic Severity Score by Clinical-Radiologic Stage
时间窗: 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.
次要结局
- Prevalence of Individual Histopathologic Features(At final histopathology assessment of the index surgical specimen. 3 months)