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Asian Outcomes of Primary Breast Augmentation (BA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235285
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : September 21, 2015
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Winners Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Augmentation
Intervention Procedure: primary breast augmentation
Enrollment 162
Recruitment Details Retrospective analysis was performed on 162 patients undergoing primary breast augmentation by a single surgeon during a 5-year period from 2010 to 2015.
Pre-assignment Details This study presents data for 162 primary breast augmentation in either alone (n=152; 93.82 percent) or in conjunction with mastopexy (n=9; 5.56 percent) and inverted nipple correction (n=1; 0.62 percent) .
Arm/Group Title Breast Augmentation,Reoperation
Hide Arm/Group Description The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
Period Title: Overall Study
Started 162
Completed 149
Not Completed 13
Arm/Group Title All Study Participants
Hide Arm/Group Description Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
Overall Number of Baseline Participants 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
<=18 years
0
   0.0%
Between 18 and 65 years
162
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants
33.98  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants
Female
162
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 162 participants
162
1.Primary Outcome
Title Post Surgical Complications and Reoperation Rate During Breast Augmentation
Hide Description The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Breast Augmentation, Reoperation
Hide Arm/Group Description:
The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: percentage of participants
reoperation rate 1.85  (0.05)
complications 1.85  (0.05)
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Breast Augmentation, Reoperation
Hide Arm/Group Description The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
All-Cause Mortality
Breast Augmentation, Reoperation
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Breast Augmentation, Reoperation
Affected / at Risk (%)
Total   3/162 (1.85%) 
Skin and subcutaneous tissue disorders   
Capsular contracture * 1  2/162 (1.23%) 
Rippling * 1  1/162 (0.62%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Breast Augmentation, Reoperation
Affected / at Risk (%)
Total   0/162 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Cheol Hwan Kim
Organization: The Department of Plastic Surgery, Winners Clinic
Phone: .+82.2.511.9446
EMail: winners511@naver.com
Publications:
1.Admas WP. Capsular contracture: what is it? what causes it? how can it be prevented and managed? Clinic Plastic Surg 36:119-126, 2009. 2.Spear SL, Murphy DK, Slicton A, et al. for the Inamed Silicon Breast Implant US Study Group. Inamed silicon breast implant core study results at 6 years. Plast Reconstr Surg 120;8s, 2007.
Layout table for additonal information
Responsible Party: Winners Clinic
ClinicalTrials.gov Identifier: NCT02235285    
Other Study ID Numbers: Breast Augmentarion
First Submitted: September 5, 2014
First Posted: September 9, 2014
Results First Submitted: June 19, 2015
Results First Posted: September 21, 2015
Last Update Posted: May 4, 2018