Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change
Condition: Contour Irregularity of Reconstructed Breast
Study type: Interventional

Summary: 
      The purpose of this study is to explore the volume change and location of volume change in
      reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to
      investigate the safety of using CPX3® in tissue-expander breast reconstruction via a
      comparison between the complication rates that result from this study and the complication
      rates with the use of other tissue expander types, as reported in the literature. We also
      hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and
      lower breast volume change and location of this volume change in the reconstructed breast.
      Finally, we intend to provide reconstructive surgeons with a scientific study that quantifies
      the patient satisfaction with aesthetic results of CPX3 in tissue expander-implant breast
      reconstruction. We hypothesize that the CPX3 tissue expander will provide more lower pole
      volume expansion when compared to lower pole volume expansion from round, standard tissue
      expanders as reported in the literature. Additionally, we hypothesize that CPX3, in
      combination with human acellular dermis, is less prone to complications than standard tissue
      expanders (again, as reported in the literature).
    

Detailed description: 
      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.

      This will be a prospective study. Fifteen patients will be enrolled and will receive a
      Contour profile tissue expander (CPX3) during their reconstruction.
    

Intervention name(s): Contour Profile Tissue Expander
Intervention type(s): Device
Intervention description(s): The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.
Other intervention name(s): CPX3
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer Reconstruction; Tissue Expander; 3-D Camera; Breast Reconstruction; Crescentric; Expander Profile; Fill-Volume; Lower Pole; Upper Pole; Acellular Dermis; 3-D Imaging