An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Number of Subjects With Breast Implant Rupture
研究概览
简要总结
A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.
详细描述
This was an observational, multicenter study conducted to investigate the long term follow-up of subjects who had been exposed to study drug (either SKY0402, bupivacaine HCl, or both) in prior SKY0402 breast augmentation studies. Specifically, the protocol was designed to elicit any changes in the response of the silicone shell of the implant after exposure to study drug.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Participated in either Pacira SKY0402-C-210 or Pacira SIMPLE Breast Augmentation 315 and received a dose of SKY0402, bupivacaine HCl, or both
- •Able and willing to comply with all study visits and procedures.
- •Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments.
- •Able and willing to provide written informed consent
排除标准
- •Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation
- •Has a clinically significant systemic or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments.
研究组 & 干预措施
Bupivacaine and low dose SKY0402
干预措施: Questionnaire and Physical Exam (Drug)
Bupivacaine and high dose SKY0402
干预措施: Questionnaire and Physical Exam (Drug)
Bupivacaine
干预措施: Questionnaire and Physical Exam (Drug)
High dose SKY0402
干预措施: Questionnaire and Physical Exam (Drug)
结局指标
主要结局
Number of Subjects With Breast Implant Rupture
时间窗: 12 to 24 months post surgery
Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty
次要结局
未报告次要终点