Mammaplasty Clinical Trial
— LipofillingOfficial title:
LIPOFILLING IN BREAST SURGERY: VOLUMETRIC EVALUATION OF FAT RESORPTION AFTER WASHING WITH RINGER'S LACTATE
Verified date | January 2017 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | Malaysia: Ministry of Health |
Study type | Observational |
Prospective observational study to evaluate effects on washing to improve viability of fat grafts in breast lipofilling.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with breast defect post breast surgery and unsatisfied. The first lipofilling procedure delayed for at least 9 months after the completion of radiotherapy. Patient on chemotherapy deferred until at least 6 month of last chemotherapy. Exclusion Criteria: - Patients are excluded if they experienced local recurrence or distant metastasis |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Malaysia | University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure fat graft resorption rate after washing with buffered lactate by volumeric MRI imaging | MRI Breast performed before the first lipofilling session, at 1st and 6th months after the lipofilling procedure. Volume measurement performed using OsiriX (v7.0.3, 64 bit , Pixmeo c) | 6 month after breast lipofilling | No |
Secondary | Confounding factors | To identify confounding factors that affect fat resorption rate in breast lipofilling To evaluate the fat resorption following breast lipofilling with volumetric MRI imaging | 6 month after breast lipofilling | No |
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