search
Back to results

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

Primary Purpose

Cancer, Breast

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Harvesting method and Fat graft preparation method
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer, Breast

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient going Oncoplastic Breast surgeries

Arm Description

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

Outcomes

Primary Outcome Measures

Cosmetic apperance
Volumetric evaluation of breast after surgery and symmetry to the other breast

Secondary Outcome Measures

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

Full Information

First Posted
December 27, 2021
Last Updated
June 15, 2022
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT05424666
Brief Title
The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction
Official Title
The Role of Lipofilling After Oncoplastic Breast Surgeries : Evaluation of Outcomes and Patient Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient going Oncoplastic Breast surgeries
Arm Type
Experimental
Arm Description
Lipofilling After Oncoplastic Breast surgeries : Evaluation of Outcomes and Patient Satisfaction
Intervention Type
Procedure
Intervention Name(s)
Harvesting method and Fat graft preparation method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cosmetic apperance
Description
Volumetric evaluation of breast after surgery and symmetry to the other breast
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Complications during the treatment and follow up
Description
Complications during the treatment Follow-up period will be registered and compared between the intervention and control groups
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mina Rashad
Phone
+201016633429
Email
minarashad36@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Kema, Study director

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Age / sex / clincal diagnosis
IPD Sharing Time Frame
3 years
IPD Sharing Access Criteria
Assiut university

Learn more about this trial

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

We'll reach out to this number within 24 hrs