Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

Completed

• Conditions: Radiation Therapy Complication; Breast Reconstruction; Prepectoral Breast Reconstruction
• Interventions: Procedure: Prepectoral breast reconstruction with polyurethane implants

• Registration Number: NCT06216106
• Lead Sponsor: European Institute of Oncology

Brief 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.

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 Timeline

• Study Start: 2020-03-18
• Primary Completion: 2022-12-22
• Status Verified: 2023-09
• Study Completion: 2023-10-05
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 237

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergone prepectoral breast reconstruction	Prepectoral breast reconstruction with polyurethane implants	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Lombardy, Italy