Brava and Fat Transfer for Breast Reconstruction

Phase 1

• Conditions: Fat Necrosis of Breast
• Interventions: Device: Brava

• Registration Number: NCT02583607
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the most sophisticated methods of breast reconstruction is using of autologous fat grafting. Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final results of fat grafting.

Detailed Description

The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-20
• Last Update Submitted: 2015-10-20
• Study First Posted: 2015-10-22
• Last Update Posted: 2015-10-22
• Primary Completion: 2016-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• woman after mastectomy

Exclusion Criteria

• smokers
• collagen disease
• low compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brava and fat transfer	Brava	The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

Primary Outcome Measures

Name	Time	Method
Number of patients satisfied with breast reconstruction using Brava and fat transfer	6 months	patients undergoing breast mastectomy will undergo breast reconstruction using the Brava and fat transfer, and will be assessed by a certified plastic surgeon who will not be a part of the study.