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N/A Completed N=12 Treatment

Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change

Contour Irregularity of Reconstructed Breast
Source: ClinicalTrials.gov NCT01222390 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Breast Projection — 19.8205 percentage loss of projection

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Breast Projection
19.8205

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01222390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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