Breast Fat Grafting Augmentation in Chinese Women

Breast Implantation Clinical Trial

Official title:

Magnetic Resonance Imaging and Breast-Q Evaluation After Breast Autologous Fat Grafting Augmentation in Chinese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551939
• Other study ID #: 201352
• Status: Completed
• Phase: N/A
• First received: September 13, 2015
• Last updated: September 15, 2015
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A total of 38 Chinese healthy women underwent autologous fat grafting for cosmetic breast augmentation. Breast volumes were measured by magnetic resonance imaging preoperatively and 1 year after the procedure. Furthermore, BREAST-Q was used to analyze the satisfaction and well-being of patients during the preoperative and 1 year post operation.

Description:

Autologous fat was obtained from thighs, waist or abdomen using resonance liposuction instrument. Fat was injected into the tissues in a multitunnel and multilayer way until they were firm and appeared fully tumesced according to the Coleman method.All MRI volume analyses were blindly performed by examiner independently preoperatively and 1 year postoperatively. Object marking was done using avanto 1.5T superconducting magnetic resonance scanner.Volume analysis was done by counting pixels within the frames of the MRI using ImageChecker CAD software.The Chinese version of BREAST-Q augmentation module was obtained from the Memorial Sloan-Kettering Cancer Center and the University of British Columbia. 38 patients were given the BREAST-Q questionnaire to express their thoughts preoperatively and 1 year postoperatively. Data were calculated using the Q-score program, which converts raw BREAST-Q scores of 1 through 4 or 5 to scores of 0 to 100.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Healthy women agreed to participate in the study

Exclusion Criteria:

• Patients who had breast surgery previously

• Women on the lactation or gestation period

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Implantation

Intervention

Procedure:
• Autologous Fat Grafting
Autologous Fat Grafting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast volumes were measured by magnetic resonance imaging		one year	Yes
Primary	BREAST-Questionaire was used to analyze the satisfaction and well-being of patients		one year	No