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

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ClinicalTrials.gov Identifier: NCT01076686
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : May 14, 2012
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Description
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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.

Condition or disease Intervention/treatment
Postoperative Pain Drug: Questionnaire and Physical Exam

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 Design
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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess the Long-Term Follow-Up of Subjects Who Had Participated in SKY0402 Breast Augmentation Studies
Study Start Date : February 2010
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Bupivacaine and low dose SKY0402 Drug: Questionnaire and Physical Exam
A 10-question survey and a six-item physical exam were completed.
Bupivacaine and high dose SKY0402 Drug: Questionnaire and Physical Exam
A 10-question survey and a six-item physical exam were completed.
Bupivacaine Drug: Questionnaire and Physical Exam
A 10-question survey and a six-item physical exam were completed.
High dose SKY0402 Drug: Questionnaire and Physical Exam
A 10-question survey and a six-item physical exam were completed.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Breast Implant Rupture [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who had been exposed to study drug and had undergone breast augmentation.
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01076686    
Other Study ID Numbers: SKY0402-C-318
First Posted: February 26, 2010    Key Record Dates
Results First Posted: May 14, 2012
Last Update Posted: May 14, 2012
Last Verified: December 2011
Keywords provided by Pacira Pharmaceuticals, Inc:
Augmentation mammoplasty
Breast augmentation
Postoperative pain
Analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations