N/A
Completed N=25
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
Source: ClinicalTrials.gov NCT01823107 ↗Enrolled (actual)
25
Serious AEs
28.0%
Results posted
Sep 2019
Primary outcomePrimary: Rate of Breast Related Adverse Events — 12 Reconstructed breasts affected
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.
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 | — |
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. Informational only — not medical advice.