Breast Fat Grafting Augmentation in Chinese Women

• Sponsor: Nanjing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02551939
• Collaborator: (none)
• Enrollment: 38
• Arm: 1
• Duration (Months): 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Implantation	Procedure: Autologous Fat Grafting	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Magnetic Resonance Imaging and Breast-Q Evaluation After Breast Autologous Fat Grafting Augmentation in Chinese Women
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fat graft Autologous Fat Grafting	Procedure: Autologous Fat Grafting; Autologous Fat Grafting

Outcome Measures

Primary Outcome Measures

1. Breast volumes were measured by magnetic resonance imaging [one year]

2. BREAST-Questionaire was used to analyze the satisfaction and well-being of patients [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jun Li, Doctor， head of the Department of Plastic & Cosmetic Surgery, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT02551939
• Other Study ID Numbers: 201352
• First Posted: Sep 16, 2015
• Last Update Posted: Sep 16, 2015
• Last Verified: Sep 1, 2015

Study Results

No Results Posted as of Sep 16, 2015