Volumetric Study of Fat Resorption After Breast Lipofilling

Sponsor

University of Malaya (Other)

Overall Status

Completed

CT.gov ID

NCT03016663

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cosmetic Techniques Mammaplasty	Procedure: Technique of Breast Lipofilling

Study Design

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

LIPOFILLING IN BREAST SURGERY: VOLUMETRIC EVALUATION OF FAT RESORPTION AFTER WASHING WITH RINGER'S LACTATE

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Breast Lipofilling Technique 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	Procedure: Technique of Breast Lipofilling Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker. Fat Harvesting Berlin autologous lipotransplantation technique used according to the BEAULI protocol described by Ueberreiter et al. Infiltration solution -"Klein'solution" contains 1 cc of epinephrine (1:500,000) diluted in 500 cc of 0.001% lactate ringer solution (LRS). Fat Processing After aspiration of nonviable components of the aspirate, fat graft washed using Lactate Ringer Solution for three times. The fat processing and washing were performed by the same assistant for all patients. Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn. Periglandular planes and intrapectoral planes are used. Intraparenchymal injection avoided.

Arm

Intervention/Treatment

Breast Lipofilling Technique

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

Procedure: Technique of Breast Lipofilling

Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker. Fat Harvesting Berlin autologous lipotransplantation technique used according to the BEAULI protocol described by Ueberreiter et al. Infiltration solution -"Klein'solution" contains 1 cc of epinephrine (1:500,000) diluted in 500 cc of 0.001% lactate ringer solution (LRS). Fat Processing After aspiration of nonviable components of the aspirate, fat graft washed using Lactate Ringer Solution for three times. The fat processing and washing were performed by the same assistant for all patients. Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn. Periglandular planes and intrapectoral planes are used. Intraparenchymal injection avoided.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Malaya Medical Centre	Lembah Pantai	Kuala Lumpur	Malaysia	59100

Sponsors and Collaborators

University of Malaya

Investigators

Principal Investigator: Alizan ABDUL KHALIL, Department of Surgery University Malaya Medical Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Malaya

ClinicalTrials.gov Identifier:

NCT03016663

Other Study ID Numbers:

RP046D-15HTM

First Posted:

Jan 10, 2017

Last Update Posted:

Jan 10, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Jan 10, 2017