NL-OMON55565
Completed
Not Applicable
the BREAST trial (the Breast Reconstruction with External pre-expansion and Autologous fat transfer vs Standard Therapy trial) - the BREAST trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast reconstruction
- Sponsor
- niversiteit Maastricht
- Enrollment
- 196
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Female gender
- •\* Age of 18 years and older
- •\* History or in candidate for a mastectomy procedure in the near future,
- •including patients undergoing a preventive mastectomy
- •\* Patients\* choice to undergo a breast reconstruction
- •\* Wanting to participate in this study
- •\* Patient is able to wear the BRAVA device
Exclusion Criteria
- •\* Active smoker or a history of smoking 4 weeks prior to surgery
- •\* Current substance abuse
- •\* History of lidocaine allergy
- •\* History of silicone allergy
- •\* 4 weeks or less after chemotherapy
- •\* History of radiation therapy in the breast region
- •\* Oncological treatment includes radiotherapy after mastectomy
- •\* Kidney disease
- •\* Steroid dependent asthma (daily or weekly) or other diseases
- •\* Immune\-suppressed or compromised disease
Outcomes
Primary Outcomes
Not specified
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