Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

Breast Reconstruction Clinical Trial

— IBR-PPBR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216106
• Other study ID #: UID 4260
• Status: Completed
• Start date: March 18, 2020
• Est. completion date: October 5, 2023

Study information

• Verified date: September 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: October 5, 2023
• Est. primary completion date: December 22, 2022
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction
• Radiation Therapy Complication

Intervention

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.

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reconstruction failure	loss of implant or switch to autologus recosntruction	12 months
Primary	major complications	evaluation of hematoma, infection, flap necrosis, wound dehiscence rate	12months
Primary	minor complications	evaluation of seroma, rippling, casular contracture, asymmetry rate	12 months
Primary	risk factor	evaluation of the risk factors correlated to recostruction failure	12 months
Secondary	postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes	evaluation if the post operative radiation therapy is correlated with an increase of reconstruction failure and capsular contracture	12 months
Secondary	patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes	analysis of clinical characteristics of pre irradiatred patients submitted to prepectoral breast recosntruction with polyurethane implantes	12 months