The primary effectiveness objective of this study is to determine whether breast reconstruction with fat grafting is more successful with the EVEBRA Device than a breast reconstruction with fat grafting without the EVEBRA.The primary safety…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All women will have an MRI for Baseline Breast Volume measurement at the time
of enrollment. Final breast volume will be also determined by MRI 12 months
after the first grafting procedure (AFT#1).
The primary effectiveness endpoint is the Percentage Augmentation of the
mastectomy defect at 12 months after AFT#1.
Secondary outcome
- The quality of the reconstructed breast tissue as determined by MRI.
(Presence of necrotic cysts, their size and number)
- The patient reported satisfaction at baseline and post-AFT using the Breast-Q
Questionnaire
- Return of sensation to the breast as determined by Semmes-Weinstein
monofilaments (map of the reconstructed breast mound with record of sensory
levels)
- Visual/standard photographic appearance of the reconstructed breast
- Difference in chest circumference between the peak of the reconstructed
breast mound and the circumference just below the inframammary line
- Difference in bra cup size
- Difference in Breast Volume Increase from the randomization baseline after
the three sessions of fat grafting (Final Reconstructed Breast Volumes) as
measured by the validated Vectra 3D imaging system and the MRI.
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.
The Breast-trial and the Breast-II study the effectiveness of autologous fat
transfer (AFT) as a full breast reconstruction method. In these studies, the
AFT treatment is combined with the use of external vacuüm expansion (EVE). The
added value of the EVE has not been investigated yet and studies treating AFT
for total breast reconstruction without the use of the EVE have been published
worldwide. Because the use of the EVE is experienced as a burden by patients,
e.g. time straining, skin irritations, pain and sleepless nights, clinical
evidence on the efficacy of the EVE in combination with AFT is necessary.
Study objective
The primary effectiveness objective of this study is to determine whether
breast reconstruction with fat grafting is more successful with the EVEBRA
Device than a breast reconstruction with fat grafting without the EVEBRA.
The primary safety objective is to record adverse events during the course of
the study and assess the safety of the EVEBRA Device in women undergoing
post-mastectomy breast reconstruction with AFT.
This study also 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
The study is designed as a prospective, multicenter randomized, controlled,
trial (RCT) of 90 post-mastectomy subjects at 5 sites. in the Netherlands. The
study will employ a 2:1 randomization of patients receiving EVEBRA +AFT
(treatment group) and patients not receiving EVEBRA, only AFT (control group).
Intervention
EVEBRA group: Subjects randomized into the EVEBRA group will receive the EVEBRA
Device.
Control group: The control subjects will receive a conventional AFT breast
reconstruction, without the use of the EVEBRA.
Both groups will receive a breast reconstruction using AFT.
Study burden and risks
To date, no studies have been performed to investigate the added value of the
EVE when used in combination with AFT for total breast reconstruction. In
contrast, reconstructive surgeons worldwide have published positive results of
AFT procedures without the use of the EVE. AFT for total breast reconstruction
is considered effective and safe. Additionally, The EVE device is experienced
by a burden by patients because of its time straining features, skin
irritations, insomnia and social consequences. This randomized control trial
will provide more information on the effectiveness of the EVEBRA in combination
with autologous fat transfer, without compromising the safety of the patients
not receiving the EVEBRA treatment. All patients will receive the same
qualitative AFT reconstruction surgery by trained plastic surgeons.
Possible consequences:
- This technique is still a rising one, results can be difficult to to predict
- The injected volume can decrease in a way that the reconstructed breast will
stay smaller than the healthy breast
- During this study, patients will undergo 3 operations during this
reconstruction period. De reconstruction period is therefore prolongued
(estimated * - 1 year), because of the need for repeated surgeries. We expect
that repeated surgeries won't be necessary in the future, because of the use of
autologous tissue.
- If randomized to EVEBRA intervention group: wearing of EVE device can be
experienced as a burden. EVEBRA will be used for a total of 4 weeks (2 weeks
before- and 2 weeks after each surgery)
- If randomized to the control group: not wearing of the EVE device does not
lead to any medical risks. It is possible that an extra surgery is necessary,
this will be discussed with your plastic surgeon.
- Extra measurements, for the evaluation of the breast reconstruction. No
medical risk related.
- Hospitalization
Burden:
- 2x extra controls, time 20 min.
- 3x questionnaires, time 10 min.
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 - Patients undergoing preventive
mastectomy - Patients* choice to undergo a breast reconstruction - Wanting to
participate in this study - Patient is able to wear the external expansion
device
Exclusion criteria
• untreated breast cancer
• history of radiation therapy on the involved breast, even if it was part of a
previous breast conservation procedure
• completed chemotherapy course less than 2 months prior
• except for the biopsy leading to the diagnosis of cancer, had surgery to
breast prior to the mastectomy
• had mastectomy wound healing complications
• mastectomy defect/scar has significant skin excess and deep folds adherent to
the chest wall
• has a pacemaker or aneurysm clips
• pregnancy or breastfeeding
• had a cardiac stent placed within the last 2 months
• claustrophobic
• known current substance abuse
• history of silicone allergy
• history of Gadolinium allergy
• history of lidocaine allergy
• bleeding diathesis, whether primary or iatrogenic
• cigarette smoker and/or Smokeless cigarette smokers
• medical conditions that preclude breast reconstruction including uncontrolled
hypertension or diabetes, renal failure, steroid dependent asthma, and on
immuno- suppressant medications, as reported by patient
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 | NCT05003635 |
| CCMO | NL72809.068.20 |