Clinical Trials Logo
  1. Home
  2. Radiation Therapy Complication
  3. NCT06216106

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
See also
  Status Clinical Trial Phase
Recruiting NCT03757793 - Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
Completed NCT05491473 - Negative Pressure in PAP Donor Sites
Not yet recruiting NCT06013514 - Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Completed NCT02169011 - Secondary Breast Reconstruction With a Flap of Skin From the Back N/A
Completed NCT01216319 - Evaluation of the Cook Biodesign Plastic Surgery Matrix N/A
Not yet recruiting NCT00973544 - Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis? N/A
Completed NCT01176786 - Reusable Versus Disposable Draping System in Breast Reconstruction Surgery N/A
Active, not recruiting NCT00748722 - Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography N/A
Completed NCT00753922 - Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses Phase 3
Completed NCT05897463 - Nipple Neurotization
Recruiting NCT05377723 - Abdominal Scar Improvement in Microsurgical Breast Reconstruction N/A
Completed NCT04350411 - Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction N/A
Completed NCT06321549 - New Era of DIEP With Minimally Invasive Mastectomy
Withdrawn NCT03135392 - Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer N/A
Completed NCT01256502 - The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery N/A
Active, not recruiting NCT04715802 - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Active, not recruiting NCT04491591 - Implementing BREASTChoice Into Practice N/A
Recruiting NCT04661501 - BREAST ADM Trial for Alloplastic Breast Reconstruction N/A
Suspended NCT03625765 - Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye N/A
Withdrawn NCT00778947 - Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction N/A