Volumetric Study of Fat Resorption After Breast Lipofilling

Completed

• Conditions: Mammaplasty; Cosmetic Techniques
• Interventions: Procedure: Technique of Breast Lipofilling

• Registration Number: NCT03016663
• Lead Sponsor: University of Malaya

Brief Summary

Prospective observational study to evaluate effects on washing to improve viability of fat grafts in breast lipofilling.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-10
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Lipofilling Technique	Technique of Breast Lipofilling	Preliminary MRI breast were performed for volumetric measurement. Fat harvesting performed by same surgeon using water-assisted liposuction (WAL) and subsequent washing with buffered lactate in a standardized technique. Fat transfer performed using Berlin autologous lipotransplantation technique according to the BEAULI protocol .Patient were followed up monthly and MRI breast were repeated at 1st and 6th months after lipofilling. Clinical assessment and MRI Volumetric measurement performed using OsiriX (v7.0.3, 64 bit, Pixmeo c) software by same radiologist based on predefined operational procedure

Primary Outcome Measures

Name	Time	Method
Measure fat graft resorption rate after washing with buffered lactate by volumeric MRI imaging	6 month after breast lipofilling	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)

Secondary Outcome Measures

Name	Time	Method
Confounding factors	6 month after breast lipofilling	To identify confounding factors that affect fat resorption rate in breast lipofilling To evaluate the fat resorption following breast lipofilling with volumetric MRI imaging

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Lembah Pantai, Kuala Lumpur, Malaysia