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

NCT ID: NCT01076686

Last Updated: 2012-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-03-31

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.

Conditions

Postoperative Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bupivacaine and low dose SKY0402

Questionnaire and Physical Exam

Intervention Type: DRUG

A 10-question survey and a six-item physical exam were completed.

Bupivacaine and high dose SKY0402

Questionnaire and Physical Exam

Intervention Type: DRUG

A 10-question survey and a six-item physical exam were completed.

Bupivacaine

Questionnaire and Physical Exam

Intervention Type: DRUG

A 10-question survey and a six-item physical exam were completed.

High dose SKY0402

Questionnaire and Physical Exam

Intervention Type: DRUG

A 10-question survey and a six-item physical exam were completed.

Interventions

Questionnaire and Physical Exam

A 10-question survey and a six-item physical exam were completed.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J. 2012 Feb;32(2):186-93. doi: 10.1177/1090820X11434524. Epub 2012 Jan 11.

Reference Type: DERIVED

PMID: 22238339 (View on PubMed)

Other Identifiers

SKY0402-C-318

Identifier Type: -

Identifier Source: org_study_id