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Completed

NCT Number: NCT03016663

Volumetric Study of Fat Resorption After Breast Lipofilling

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

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Key information

Conditions

Cosmetic Techniques Mammaplasty

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technique of Breast Lipofilling

Procedure
  • 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  • Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn.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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Acronym: Lipofilling

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2017
Registry last updated
Jan 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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