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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076686
• Other study ID #: SKY0402-C-318
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: April 15, 2012
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: December 2011
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Questionnaire and Physical Exam
A 10-question survey and a six-item physical exam were completed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Breast Implant Rupture	Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty	12 to 24 months post surgery