Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

NCT06216106 | Completed

• 1 other identifier: UID 4260
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

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.

Conditions

Prepectoral Breast Reconstruction; Breast Reconstruction; Radiation Therapy Complication

Keywords

PPBR; POLYURETHANE; IBR; RADIOTHERAPY; BREAST IMPLANTS

Outcome Measures

Primary Outcomes (4)

• reconstruction failure

  loss of implant or switch to autologus recosntruction

  12 months

• major complications

  evaluation of hematoma, infection, flap necrosis, wound dehiscence rate

  12months

• minor complications

  evaluation of seroma, rippling, casular contracture, asymmetry rate

  12 months

• risk factor

  evaluation of the risk factors correlated to recostruction failure

  12 months

Secondary Outcomes (2)

• postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes

  12 months

• patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes

  12 months

Study Arms (1)

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

Interventions

Prepectoral breast reconstruction with polyurethane implants PROCEDURE

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.

patients undergone prepectoral breast reconstruction

Eligibility Criteria

• Gender Eligibility Details: we included only famale patients underwent mastectomy and immediate breast reconstruction in the prepectoral plane with polyurethane implantes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patientes undergone immediate prepectoral breast reconstruction with polyurethane implantes

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Lombardy, 20141, Italy

Location

Related Publications (2)

• Salgarello M, Pagliara D, Barone Adesi L, Visconti G, Wild JB, Matey P. Direct to Implant Breast Reconstruction With Prepectoral Micropolyurethane Foam-Coated Implant: Analysis of Patient Satisfaction. Clin Breast Cancer. 2021 Aug;21(4):e454-e461. doi: 10.1016/j.clbc.2021.01.015. Epub 2021 Jan 23.

  PMID: 33627298 BACKGROUND

• de Vita R, Buccheri EM, Villanucci A, Pozzi M. Breast Reconstruction Actualized in Nipple-sparing Mastectomy and Direct-to-implant, Prepectoral Polyurethane Positioning: Early Experience and Preliminary Results. Clin Breast Cancer. 2019 Apr;19(2):e358-e363. doi: 10.1016/j.clbc.2018.12.015. Epub 2018 Dec 27.

  PMID: 30691930 BACKGROUND

Study Officials

• Andrea Vittorio Emanuele Lisa

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 22, 2024
• Study Start: March 18, 2020
• Primary Completion: December 22, 2022
• Study Completion: October 5, 2023
• Last Updated: January 22, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)