Prospective Stage-Stratified Histopathologic Study and Proposed Disease-Evolution Model of Gluteal Permanent Synthetic Filler Complications
2026年9月7日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
观察性的
注册 (估计的)
200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Edison Osorio, MD, Plastic surgeon
- 电话号码：+573226140611
- 邮箱：info@edisonosorio.com
学习地点
-
-
Antioquia
-
Medellín、Antioquia、哥伦比亚
- Clinica Bioforma
-
接触：
- Edison Osorio, MD, Plastic surgeon
- 电话号码：+573226140611
- 邮箱：info@edisonosorio.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults undergoing biopsy or surgical removal of gluteal tissue affected by permanent synthetic filler, spanning early exposure through advanced disease with ulceration or necrosis.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite Histopathologic Severity Score by Clinical-Radiologic Stage
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of Individual Histopathologic Features
大体时间：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.
|
At final histopathology assessment of the index surgical specimen. 3 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Histopathologic Phenotype Classification
大体时间：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.
|
After completion of tissue collection and database lock, using data from the index specimen. 1 year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Edison Osorio, MD, plastic surgery
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月7日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 009 (Nahrain Medical Research Collective (NMRC))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
not considered in the informed consent of the patients
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.