Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change

NCT01222390 | Completed Results DMC

• 1 other identifier: G10-0056
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Breast Projection

  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

Study Arms (1)

Contour Profile Tissue Exander

EXPERIMENTAL

Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).

Device: Contour Profile Tissue Expander

Interventions

Contour Profile Tissue Expander DEVICE

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.

Also known as: CPX3

Contour Profile Tissue Exander

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Mentor Worldwide, LLC: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• 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.

  PMID: 22286418 RESULT

• 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.

  PMID: 23562485 RESULT

• 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.

  PMID: 14578788 RESULT

Limitations and Caveats

The number of subjects studied is small; projection measurements may have been subject to human error.

Results Point of Contact

• Title: John Y.S. Kim, MD
• Organization: Northwestern University

jokim@nmh.org

312-695-0208

Study Officials

• John YS Kim, MD, MA

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Division of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 18, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 6, 2023
• Results First Posted: November 17, 2014

Record last verified: 2023-03

Locations

US (1)