the BREAST trial (the Breast Reconstruction with External pre-expansion and Autologous fat transfer vs Standard Therapy trial)

Completed

Conditions: Breast reconstruction
10006295

Registration Number: NL-OMON55565

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 196

Inclusion Criteria

* Female gender
* Age of 18 years and older
* History or in candidate for a mastectomy procedure in the near future,
including patients undergoing a preventive mastectomy
* Patients* choice to undergo a breast reconstruction
* Wanting to participate in this study
* Patient is able to wear the BRAVA device

Exclusion Criteria

* Active smoker or a history of smoking 4 weeks prior to surgery
* Current substance abuse
* History of lidocaine allergy
* History of silicone allergy
* 4 weeks or less after chemotherapy
* History of radiation therapy in the breast region
* Oncological treatment includes radiotherapy after mastectomy
* Kidney disease
* Steroid dependent asthma (daily or weekly) or other diseases
* Immune-suppressed or compromised disease
* Uncontrolled diabetes
* BMI>30
* Large breast size (i.e. larger than cup C), unless the patient prefers
reduction of the contralateral side towards Cup C
* Extra-capsular silicone leaking from the encapsulated implant from a previous
breast reconstruction
* The treating plastic surgeon has strong doubts on the patient*s treatment
compliance

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The patients* quality of life will be the main outcome measure of this study,<br /><br>using the BREAST-Q questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The quality of the breast reconstruction will be measured by the volume and<br /><br>shape over time (3D photography or MRI), skin quality (cutometer), patient<br /><br>satisfaction (questionnaire) and aesthetic judgement (panel rating pre- and<br /><br>post operative photos). Complications during treatment and follow-up will be<br /><br>registered and compared. Oncologic safety will be monitored for five years. At<br /><br>last, a cost-effectiveness analysis will be performed to research the economic<br /><br>characteristics of this new technique versus the standard technique.</p><br>