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

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Questionnaire and Physical Exam

• Registration Number: NCT01076686
• Lead Sponsor: Pacira Pharmaceuticals, Inc

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-11-06
• Status Verified: 2011-12
• Results First Submitted QC: 2012-04-15
• Last Update Submitted: 2012-04-15
• Results First Posted: 2012-05-14
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• 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

Exclusion Criteria

• Did not receive study drug in either Pacira SKY0402-C-210 or SIMPLE Breast Augmentation 315.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Questionnaire and Physical Exam	-
Bupivacaine and low dose SKY0402	Questionnaire and Physical Exam	-
Bupivacaine and high dose SKY0402	Questionnaire and Physical Exam	-
High dose SKY0402	Questionnaire and Physical Exam	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Breast Implant Rupture	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