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Completed

NCT Number: NCT06216106

Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

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.

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Key information

Conditions

Prepectoral Breast Reconstruction Breast Reconstruction Radiation Therapy Complication

Sex eligibility

Female

Study type

Observational

Primary location

European Institute of Oncology

Milan, Lombardy, 20141, Italy

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. reconstruction failure

    Time frame: 12 months

    loss of implant or switch to autologus recosntruction

  2. major complications

    Time frame: 12months

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

  3. minor complications

    Time frame: 12 months

    evaluation of seroma, rippling, casular contracture, asymmetry rate

  4. risk factor

    Time frame: 12 months

    evaluation of the risk factors correlated to recostruction failure

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: IBR-PPBR

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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