Brava and Fat Transfer for Breast Reconstruction

Shaare Zedek Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Fat Necrosis of Breast

Treatments: Device: Brava

Study type: Interventional

Funder types: Other

Identifiers

NCT02583607

81/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• woman after mastectomy

Exclusion criteria

• smokers
• collagen disease
• low compliance

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Brava and fat transfer

Experimental group

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.

Treatment:

Device: Brava