N/A
N=12
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change
Contour Irregularity of Reconstructed Breast
Bottom Line
View on ClinicalTrials.gov: NCT01222390 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Breast Projection — 19.8205 percentage loss of projection
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contour Profile Tissue Expander (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Projection |
19.8205 | — |
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).
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
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.