Trial Information

The Contour Profile® Tissue Expander in Immediate Breast Reconstruction: A Three-Dimensional Look Into Shape and Volume Changes

Tissue expansion is an accepted and widely used method for breast reconstruction. A drawback
in using standard tissue expanders is unwanted fullness at the upper pole and insufficient
expansion at the lower pole of the breast. Round expanders can result in poor ptosis
(sagging) because of unwanted upper pole fullness and are not without risk for
complications[1, 2]. Anatomically-shaped expanders also have shortcomings and complications
such as malposition[3-7]. A tissue expander designed to counteract upper pole fullness is
necessary to achieve a more natural appearing ptotic breast with a well-defined inframammary
fold (IMF)[8]. The inframammary fold is the crease below the breast where the breast meets
the chest wall. Mentor's Contour Profile® (CPX3) tissue expander provides a design with a
greater height to width ratio for greater lower pole expansion. It also has suture tabs on
the back of the expander to hold the expander in place and prevent malposition. Another
recent advancement in tissue expander breast reconstruction is the use of cadaveric-derived
human acellular dermis for rapid intraoperative expansion and early projection[9-14].

The crescent-shaped expander has been studied by John YS Kim, MD in a retrospective review
of 40 consecutive patients who underwent acellular dermis assisted breast reconstruction. He
found the crescentric tissue expansion with acellular dermis is well tolerated with high
patient and surgeon satisfaction likely due to selective lower pole expansion related to the
crescent shape, as well as significant immediate expansion related to larger subpectoral
pockets.

To date, no studies have been reported that investigate the lower pole expansion resulting
from varying tissue expander dimensions with objective computer software[15, 16]. The advent
of three-dimensional imaging technology to objectively measure lower pole expansion provides
a quantitative means to study the advantages of using the CPX3® tissue expander. We propose
a study that will show whether or not the CPX3® tissue expander's unique design can have an
ultimate effect on the shape and location of volume change on the postoperative breast.
Three-dimensional cameras also provide an advantage for assessing patients undergoing
bilateral mastectomy and reconstruction who desire a reconstructive outcome that will bear
some resemblance to their current breasts [15].

The 3-D imaging calculation evaluates the following parameters: absolute volume, absolute
volume change, location of expansion, base width, breast projection and contour symmetry.
Older methods of volume assessment would assume that the base of the breast is a flat plane.
The Vectra system takes into account the curvature of the chest wall, which results in a
more accurate breast volume measurement. With 3-D imaging there is no exposure to
radiation[16]. Another advantage to 3-D imaging is the option to view the subject's image at
any angle, 360 degrees[17]. Our study would show the postoperative results of using the
CPX3® tissue expander with an objective analysis of the degree of lower-pole expansion when
compared to standard tissue expanders.

This will be a prospective study. Fifteen patients will be enrolled in the treatment arm and
will receive a Contour profile tissue expander (CPX3) during their reconstruction. Fifteen
patients will be enrolled in the control arm and will receive a standard tissue expander
during their reconstruction.