- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01222390
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change (CPX3)
The Contour Profile® Tissue Expander in Immediate Breast Reconstruction: A Three-Dimensional Look Into Shape and Volume Changes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contour Profile Tissue Exander
Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast Projection
Time Frame: 1.5 years
|
The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery.
Upon final fill of the tissue expander, the breast has a certain projection.
Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time.
The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).
|
1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aesthetic Outcomes
Time Frame: 1.5 years
|
Aesthetic outcomes will be compared between the two groups using respective questionnaires.
Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.
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1.5 years
|
Complication Rate
Time Frame: 1.5 years
|
Complications may include hematoma, seroma, infection, implant migration, inflammation or explantation.
|
1.5 years
|
Emotional Outcomes
Time Frame: 1.5 years
|
Emotional outcomes will be compared between the two groups using respective questionnaires.
Questionnaires will be filled out pre-operatively, prior to implant exchange and 3 months following tissue expander/implant exchange.
|
1.5 years
|
Location of Volume Change
Time Frame: 1.5 years
|
3-D photos will be taken to assess the location of volume and contour changes in the breast.
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1.5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: John YS Kim, MD, MA, Northwestern University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- G10-0056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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