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The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction

The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05424666
Enrollment
20
Registered
2022-06-21
Start date
2022-12-19
Completion date
2024-09-01
Last updated
2022-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Breast

Brief summary

The Role of Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction

Detailed description

Lipofilling is the process of relocating autologous fat to change the shape, volume, consistency and profile of tissues. For over a century, surgeons have used autologous fat to enlarge and reshape the breasts. Autologous fat grafting has gained popularity in recent years, although concerns exist regarding the safety and efficacy of this practice in breast surgery . Autologous fat grafting represents an important tool for the management of secondary contour deformities of reconstructed breasts; fat grafting is a simple, safe, and effective treatment option, with low morbidity. it is a straightforward and quick reconstructive technique that does not generally interfere with adjuvant therapies .patient surveys have demonstrated that irradiation has a significant and negative effect on patient satisfaction . Fat grafting seems to reduce radiation induced complications .improve cosmetic results, and reduce postoperative discomfort and pain. The aim of this study is to measure patient satisfaction with their breasts, as well as quality of life. With the advent of liposuction in the 1980s, large amounts of unwanted fat could be removed from different body areas using small access incisions and a suction cannula. In this setting, fat grafting was re-introduced in the early 80s, pioneered by the American Mel Bircoll, who first described a series of fat transplantation for breast augmentation and reconstruction

Interventions

PROCEDUREHarvesting method and Fat graft preparation method

The procedure begins by identifying the areas where the fat will be collected Then the sample is collected by micro-incision using a fine suction cannula or during conventional liposuction. The fat cells are taken from an area of the body where there is a reserve (generally, in the abdomen, hips, knees, inner thighs, buttock) The collected fat cells are then subjected to a sterile centrifugation for a few minutes so as to separate the cells that will be injected (intact fat cells) from the elements that must not be injected (fat cells destroyed by the sample, non-fat cells such as than blood cells). Injection of fat cells into the breasts The reinjection of fat (lipofilling) is performed using micro-cannulas allowing incisions of the order of 1-2 mm in different angles and in multiple directions so as to increase the contact area between the grafted cells and the recipient tissues allowing a good grip of the injection.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Female gender. Age of 18 years and older. History or in candidate for a mastectomy in the near future. Patients undergoing prophylactic mastectomy. Patients' choice to undergo a breast reconstruction. Wanting to participate in this study. Patient is able to wear the BRAVA (BRA like VAcuum-based external tissue expander) device.

Exclusion criteria

Active smoker or a history of smoking 4 weeks prior to surgery. Current substance abuse. History of lidocaine allergy. Four weeks or less after chemotherapy. History of radiation therapy in the breast region. Oncological treatment includes radiotherapy after mastectomy. Kidney disease. Steroid dependent (daily or weekly). Immune-suppressed or immune-compromised disease. Uncontrolled diabetes. body mass index of \>30. Large breast size (ie, larger than cup C), unless the patient prefers reduction of the contralateral side towards cup C. Extracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction.

Design outcomes

Primary

MeasureTime frameDescription
Cosmetic apperance1 weekVolumetric evaluation of breast after surgery and symmetry to the other breast

Secondary

MeasureTime frameDescription
Complications during the treatment and follow up1 monthComplications during the treatment Follow-up period will be registered and compared between the intervention and control groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026