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临床试验/NCT04661969
NCT04661969已完成不适用

"Outcomes of Surgical Removal of Foreign Body Granulomas Due to Polymer Injection for Cosmetic Purposes"

Hospital Angeles del Pedregal1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Complications

研究概览

简要总结

Illicit subcutaneous injection of high-viscosity fluids for restoration and improvement of body contour is a growing trend all around the world. Many local and systemic complications have been described. Local complications include deformity at the site of injection, granulomas and several skin changes like erythema, induration, and plaques (well-circumscribed, elevated, superficial, solid lesion).

The investigator designed a single-center, cross-sectional, retrospective, consecutive case series study and evaluated 49 surgeries performed in 35 patients with the history of foreign substances injection for cosmetic purposes and developed local complications. Investigators divided 4 groups accordingly to localization of foreign substances (FS). Group 1) FS disseminated to both lower extremities and buttocks; group 2) FS isolated to buttocks with moderate to severe skin changes, Group 3) FS isolated to lower legs with mild skin changes and superficial ulcerations and 4) FS isolated to lower legs with moderate to severe skin changes and/or ulceration. The investigators treated all patients surgically, which consisted of isolate ultrasonic liposuction for extraction of the material from the affected region (group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4). Statistical analysis was performed to find relations between type of surgery with complications, reactivation of symptoms, time for reactivation and a disease-free survival test (kaplan meier) was done.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
24 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • History of injection of foreign substances for cosmetic purposes
  • Develop symptoms of Autoimmune syndrome induced by adjuvants
  • Mild to severe skin changes

排除标准

  • Refuse to participate in the analysis

结局指标

主要结局

Complications

时间窗: 30 days

Describe if patients have or not postoperative complications

次要结局

  • Reactivation of symptoms(9 to 76 months)
  • Time for reactivation of symptoms(9 to 76 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

javier lopez

Principal investigator, Plastic and reconstructive surgeon staff, MBA, FACS

Hospital Angeles del Pedregal

研究点 (1)

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