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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01076686
First received: February 25, 2010
Last updated: April 15, 2012
Last verified: December 2011
  Purpose

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 Intervention
Postoperative Pain
Drug: Questionnaire and Physical Exam

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Number of Subjects With Breast Implant Rupture [ Time Frame: 12 to 24 months post surgery ] [ Designated as safety issue: Yes ]
    Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty


Enrollment: 94
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Pacira Pharmaceuticals, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01076686     History of Changes
Other Study ID Numbers: SKY0402-C-318
Study First Received: February 25, 2010
Results First Received: November 6, 2011
Last Updated: April 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Augmentation mammoplasty
Breast augmentation
Postoperative pain
Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014