External Vacuum Expansion: evaluation in breast reconstructive surgery

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 90

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All women will have an MRI for Baseline Breast Volume measurement at the time<br /><br>of enrollment. Final breast volume will be also determined by MRI 12 months<br /><br>after the first grafting procedure (AFT#1).<br /><br>The primary effectiveness endpoint is the Percentage Augmentation of the<br /><br>mastectomy defect at 12 months after AFT#1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The quality of the reconstructed breast tissue as determined by MRI.<br /><br>(Presence of necrotic cysts, their size and number)<br /><br>- The patient reported satisfaction at baseline and post-AFT using the Breast-Q<br /><br>Questionnaire<br /><br>- Return of sensation to the breast as determined by Semmes-Weinstein<br /><br>monofilaments (map of the reconstructed breast mound with record of sensory<br /><br>levels)<br /><br>- Visual/standard photographic appearance of the reconstructed breast<br /><br>- Difference in chest circumference between the peak of the reconstructed<br /><br>breast mound and the circumference just below the inframammary line<br /><br>- Difference in bra cup size<br /><br>- Difference in Breast Volume Increase from the randomization baseline after<br /><br>the three sessions of fat grafting (Final Reconstructed Breast Volumes) as<br /><br>measured by the validated Vectra 3D imaging system and the MRI.<br /><br></p><br>