This study aims to determine the effectiveness of a new breast reconstruction technique: Autologous fat transfer (AFT). This technique combines the advantages of using the patients* own tissue (fat cells), while being minimally invasive compared to…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The patients* quality of life will be the main outcome measure of this study,
using the BREAST-Q questionnaire.
Secondary outcome
The quality of the breast reconstruction will be measured by the volume and
shape over time (3D photography or MRI), skin quality (cutometer), patient
satisfaction (questionnaire) and aesthetic judgement (panel rating pre- and
post operative photos). Complications during treatment and follow-up will be
registered and compared. Oncologic safety will be monitored for five years. At
last, a cost-effectiveness analysis will be performed to research the economic
characteristics of this new technique versus the standard technique.
Background summary
Breast cancer is the most common malignancy in females. After breast cancer,
many patients suffer from anxiety to depression. Therefore, progressively more
patients choose to have a breast reconstructed to increase her quality of life.
Study objective
This study aims to determine the effectiveness of a new breast reconstruction
technique: Autologous fat transfer (AFT). This technique combines the
advantages of using the patients* own tissue (fat cells), while being minimally
invasive compared to available techniques. So far, the research studying this
technique does not provide high quality evidence on efficacy and safety,
inhibiting the use of AFT in everyday practice.
Study design
A multicentre randomised controlled trial will determine the efficacy and
safety of the BRAVA-AFT technique. The BRAVA is the external pre-expansion of
the breast, while the AFT covers the actual surgical technique to transfer fat
cells to the breast. The BRAVA-AFT will be the intervention arm, while implants
will be the control arm, the *standard* in current breast reconstruction
techniques.
Intervention
See study design
Study burden and risks
As this technique is not applied in everyday practice in the Netherlands, we
expect that the benefits for the patients is the opportunity to have her breast
reconstructed with this autologous fat transfer (AFT) technique. Current
literature suggests less complications using AFT versus using implants in
breast reconstruction.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02339779 |
| CCMO | NL51029.068.14 |