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

NCT ID: NCT05424666

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-19
• Study Completion Date: 2024-09-01

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

Conditions

Cancer, Breast

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient going Oncoplastic Breast surgeries

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

Group Type: EXPERIMENTAL

Harvesting method and Fat graft preparation method

Intervention Type: PROCEDURE

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.

Interventions

Harvesting 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

mina rashad helmy besada

Assiut lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mina Rashad

Role: primary

minarashad36@gmail.com

+201016633429

Ahmed Kema, Study director

Role: backup

Other Identifiers

Oncoplastic breast surgeries

Identifier Type: -

Identifier Source: org_study_id