NCT01076686

Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects

An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Questionnaire and Physical Exam	A 10-question survey and a six-item physical exam were completed.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-02-26
• Last updated: 2012-05-14
• Results posted: 2012-05-14