Trial Outcomes & Findings for Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects (NCT NCT01076686)

NCT ID: NCT01076686

Last Updated: 2012-05-14

Results Overview

Breast implant rupture and integrity were assessed by reviewing the results of history and physical focused on clinical sequelae of augmentation mammoplasty

• Recruitment status: COMPLETED
• Target enrollment: 94 participants
• Primary outcome timeframe: 12 to 24 months post surgery
• Results posted on: 2012-05-14

Participant Flow

Participant milestones

Measure	Bupivacaine and Low Dose SKY0402 Single dose of study drug was injected locally into the breast pockets	Bupivacaine and High Dose SKY0402 Single dose of study drug was injected locally into the breast pockets	Bupivacaine Single dose of study drug was injected locally into the breast pockets	High Dose SKY0402 Single dose of study drug was injected locally into the breast pockets
Overall Study STARTED	17	14	32	31
Overall Study COMPLETED	17	14	32	31
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bupivacaine and Low Dose SKY0402 n=17 Participants Single dose of study drug was injected locally into the breast pockets	Bupivacaine and High Dose SKY0402 n=14 Participants Single dose of study drug was injected locally into the breast pockets	Bupivacaine n=32 Participants Single dose of study drug was injected locally into the breast pockets	High Dose SKY0402 n=31 Participants Single dose of study drug was injected locally into the breast pockets	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants	31 Participants n=4 Participants	94 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	32 years STANDARD_DEVIATION 7.2 • n=5 Participants	29 years STANDARD_DEVIATION 6.3 • n=7 Participants	31 years STANDARD_DEVIATION 7.1 • n=5 Participants	33 years STANDARD_DEVIATION 7.6 • n=4 Participants	32 years STANDARD_DEVIATION 7.2 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants	31 Participants n=4 Participants	94 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	17 participants n=5 Participants	14 participants n=7 Participants	32 participants n=5 Participants	31 participants n=4 Participants	94 participants n=21 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Bupivacaine and Low Dose SKY0402 n=17 Participants Single dose of study drug was injected locally into the breast pockets	Bupivacaine and High Dose SKY0402 n=14 Participants Single dose of study drug was injected locally into the breast pockets	Bupivacaine n=32 Participants Single dose of study drug was injected locally into the breast pockets	High Dose SKY0402 n=31 Participants Single dose of study drug was injected locally into the breast pockets
Number of Subjects With Breast Implant Rupture	0 participants	0 participants	0 participants	0 participants

Adverse Events

Bupivacaine and Low Dose SKY0402

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine and High Dose SKY0402

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Dose SKY0402

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Executive Medical Director

Pacira Pharmaceuticals

Phone: 203-837-6500

Email: erolo@pacira.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place