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Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

NCT06216106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2024-01-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Andrea Vittorio Emanuele Lisa · Istituto Europeo di Oncologia

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2022-12-22
Completion
2023-10-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06216106 on ClinicalTrials.gov