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

A

Assiut University

Status

Enrolling

Conditions

Cancer, Breast

Treatments

Procedure: Harvesting method and Fat graft preparation method

Study type

Interventional

Funder types

Other

Identifiers

NCT05424666
Oncoplastic breast surgeries

Details and patient eligibility

About

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

Full 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

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Patient going Oncoplastic Breast surgeries
Experimental group
Description:
Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction
Treatment:
Procedure: Harvesting method and Fat graft preparation method

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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