Status:
COMPLETED
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Implant; Complications
Breast Implant Infection
Eligibility:
FEMALE
Brief Summary
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patc...
Detailed Description
Radiotherapy is highly effective in breast cancer treatment, yet it impairs satisfactory implant-based reconstruction, due to high rates of capsular contracture and implant loss. This said, a fervent ...
Eligibility Criteria
Inclusion
- at least 6 months follow up
- breast reconstruction with implant + acellular dermal matrix after mastectomy and radiotherapy
Exclusion
- mastectomy flap \<1 cm
- autoimmune disease
- prolonged use of corticosteroids
Key Trial Info
Start Date :
June 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2023
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06139588
Start Date
June 1 2017
End Date
October 13 2023
Last Update
December 13 2023
Active Locations (1)
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1
European Institute of Oncology
Milan, Lombardy, Italy, 20141