Clinical trial NCT01222390: Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change
Official title: The Contour Profile® Tissue Expander in Immediate Breast Reconstruction: A Three-Dimensional Look Into Shape and Volume Changes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contour Irregularity of Reconstructed Breast
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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Mentor Worldwide, LLC
First posted: 2010-10-18
Enrollment: 12
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo unilateral or bilateral mastectomies for treatment of breast cancer with immediate tissue expander reconstruction

Exclusion Criteria:

* Patients who have had previous immediate non-expander based breast reconstruction
* Patients who have had delayed secondary flap surgery (replacing expander with autogenous tissue)
* Patients who have pacemakers and/or defibrillators which are not compatible with CPX3

Primary outcomes:
measure: Breast Projection
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: John YS Kim, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hirsch EM, Seth AK, Dumanian GA, Kim JYS, Mustoe TA, Galiano RD, Fine NA. Outcomes of tissue expander/implant breast reconstruction in the setting of prereconstruction radiation. Plast Reconstr Surg. 2012 Feb;129(2):354-361. doi: 10.1097/PRS.0b013e31823ae8b1.
citation: Mioton LM, Smetona JT, Hanwright PJ, Seth AK, Wang E, Bilimoria KY, Gaido J, Fine NA, Kim JY. Comparing thirty-day outcomes in prosthetic and autologous breast reconstruction: a multivariate analysis of 13,082 patients? J Plast Reconstr Aesthet Surg. 2013 Jul;66(7):917-25. doi: 10.1016/j.bjps.2013.03.009. Epub 2013 Apr 4.
citation: Nahabedian MY, Galdino G. Symmetrical breast reconstruction: is there a role for three-dimensional digital photography? Plast Reconstr Surg. 2003 Nov;112(6):1582-90. doi: 10.1097/01.PRS.0000085818.54980.C4.