Trial Outcomes & Findings for Macrolane Retrospective Study (NCT NCT01223963)

NCT ID: NCT01223963

Last Updated: 2022-08-26

Results Overview

Number of Adverse events reported during the study period

• Recruitment status: COMPLETED
• Target enrollment: 93 participants
• Primary outcome timeframe: 01may2008 - 31dec2009
• Results posted on: 2022-08-26

Participant Flow

Participant milestones

Measure	Macrolane Women that have had breast enhancement with Macrolane Volume Restoration Factor.
Overall Study STARTED	93
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Macrolane Retrospective Study

Baseline characteristics by cohort

Measure	Macrolane n=93 Participants Women that have had breast enhancement with Macrolane Volume Restoration Factor.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	93 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Sweden	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 01may2008 - 31dec2009

Number of Adverse events reported during the study period

Outcome measures

Measure	Macrolane n=93 Participants Number of related Adverse events reported during the study period
Number of Adverse Events	46 number of AE

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 12 months post-procedure

The alternative outcomes were: still satisfied, never satisfied, 3-5 months, 6-8 months, 9-11 months, 12 months or more, still satisfied when retreated.

Outcome measures

Measure	Macrolane n=93 Participants Number of related Adverse events reported during the study period
Number of Participants Who Reported Being at Least Somewhat Satisfied at Any Tine Post-procedure	89 participants

Adverse Events

Macrolane

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Macrolane n=93 participants at risk Women that have had breast enhancement with Macrolane Volume Restoration Factor.
General disorders Capsular contracture associated with breast implant	22.6% 21/93
General disorders Implant site nodule	8.6% 8/93

Additional Information

Chief Medical Officer

Q-Med AB

Phone: +46 18 4749000

Email: reception.seupp@galderma.com

Results disclosure agreements

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

Restriction type: LTE60