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

January 11, 2024 updated by: European Institute of Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patientes undergone immediate prepectoral breast reconstruction with polyurethane implantes

Description

Inclusion Criteria:

  • patients underwent prepectoral breast recosntruction with polyurethane implants after skin or nipple sparing masectomy
  • adequate mastectomy flap in vascularity and thickness

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergone prepectoral breast reconstruction
As the retrospective nature of this study, we have no exlusion criterias. We included all the patients with prepectoral breast reconstruction with polyurethane covered implants. We also included patients underwent postoperative radiation therapy (50 patients) and 20 patients with history of previous radiotherapy
Procedure: Prepectoral breast reconstruction with polyurethane implants
Breast reconstruction in the prepectoral plane without elevate the pectoralis major muscle. We choose this type of reconstruction only in patients with mastectomy flap thickness of plus then 0.5 cm. We usally use silicone implants covered by an external layer of polyurethane so not to put directly in contact the silicone with the subcutaneus tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reconstruction failure
Time Frame: 12 months
loss of implant or switch to autologus recosntruction
12 months
major complications
Time Frame: 12months
evaluation of hematoma, infection, flap necrosis, wound dehiscence rate
12months
minor complications
Time Frame: 12 months
evaluation of seroma, rippling, casular contracture, asymmetry rate
12 months
risk factor
Time Frame: 12 months
evaluation of the risk factors correlated to recostruction failure
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes
Time Frame: 12 months
evaluation if the post operative radiation therapy is correlated with an increase of reconstruction failure and capsular contracture
12 months
patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes
Time Frame: 12 months
analysis of clinical characteristics of pre irradiatred patients submitted to prepectoral breast recosntruction with polyurethane implantes
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Andrea Vittorio Emanuele Lisa, Istituto Europeo di Oncologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2020

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

October 5, 2023

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UID 4260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Reconstruction

Clinical Trials on Prepectoral breast reconstruction with polyurethane implants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe