N/A
N=25
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01823107 ↗Enrolled (actual)
25
Serious AEs
28.0%
Results posted
Sep 2019
Primary outcome: Primary: Rate of Breast Related Adverse Events — 12 Reconstructed breasts affected
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Meso BioMatrix Device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Kensey Nash Corporation
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Breast Related Adverse Events |
12 | — |
| SECONDARY Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey |
71.2 | — |
| SECONDARY Rate of Reconstruction Failure |
3 | — |
Summary
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction.
Eligibility Criteria
Inclusion Criteria
- Non-smoker
- Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction
- Life expectancy greater than 18 months
- Agreement to return for the trial required follow-up visits
Exclusion Criteria
- Body mass index ≥ 35
- Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty
- History of chronic corticosteroid use
- Type I Diabetes
- History of radiation therapy to the chest
- Pre-operative treatment with induction chemotherapy for breast cancer
- Pregnancy
- Participating in another investigational drug or device trial that has not completed the follow-up period
Data sourced from ClinicalTrials.gov (NCT01823107). 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.