Clinical trial NCT06216106: Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes
Official title: Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prepectoral Breast Reconstruction
Breast Reconstruction
Radiation Therapy Complication
Keywords: PPBR
POLYURETHANE
IBR
RADIOTHERAPY
BREAST IMPLANTS
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 237
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patientes undergone immediate prepectoral breast reconstruction with polyurethane implantes

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

Eligibility criteria: 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

Primary outcomes:
measure: reconstruction failure
timeFrame: 12 months
measure: major complications
timeFrame: 12months
measure: minor complications
timeFrame: 12 months
measure: risk factor
timeFrame: 12 months
Secondary outcomes:
measure: postoperative radiation therapy on patients underwent prepectoral breast reconstruction with polyurethane implantes
timeFrame: 12 months
measure: patients previously irradiated (QUART) and underwent prepectoral breast reconstruction with polyurethane implantes
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
state: Lombardy
Study officials:
affiliation: Istituto Europeo di Oncologia
name: Andrea Vittorio Emanuele Lisa
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.