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Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes — IBR-PPBR  

Breast Reconstruction Clinical Trial

Official title:
Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications

Clinical Trial Summary

The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.

Clinical Trial Description

The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (> 0.5 cm) and vascularity of skin flap after mastectomy. The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction. In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence. The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06216106
Study type Observational
Source European Institute of Oncology
Contact
Status Completed
Phase
Start date March 18, 2020
Completion date October 5, 2023
View Details
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