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Volumetric Study of Fat Resorption After Breast Lipofilling (Lipofilling)

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ClinicalTrials.gov Identifier: NCT03016663
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of Malaya

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

Condition or disease Intervention/treatment
Cosmetic Techniques Mammaplasty Procedure: Technique of Breast Lipofilling

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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 : September 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Group/Cohort 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
  1. Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker.
  2. 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).

  3. 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.
  4. 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.




Primary Outcome Measures :
  1. Measure fat graft resorption rate after washing with buffered lactate by volumeric MRI imaging [ Time Frame: 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 :
  1. Confounding factors [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with past history of breast cancer recruited.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016663


Locations
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Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Alizan ABDUL KHALIL Department of Surgery University Malaya Medical Centre
Publications:

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT03016663    
Other Study ID Numbers: RP046D-15HTM
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No