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Pre-pectoral Breast Reconstruction With or Without Mesh

Pre-pectoral Breast Reconstruction With or Without Mesh

Recruiting
18-65 years
Female
Phase N/A

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Overview

To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

Description

The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

Eligibility

Inclusion Criteria:

  1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
  2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
  3. Tissue expander size =<800cc, implant size =<600cc;
  4. The blood perfusion of breast skin flap was well;
  5. Do not smoking in the last 4 weeks or more
  6. Patients with normal expectations and mental health for breast reconstruction;
  7. Signed consent to participate

Exclusion Criteria:

  1. Poor perfusion of breast mastectomy flap;
  2. II stage breast reconstruction patients;
  3. History of chest radiotherapy;
  4. BMI greater than 35;
  5. Patients who have not quit smoking within the last 4 weeks;

Study details
    Prepectoral Breast Reconstruction
    TiLOOP Mesh

NCT05888571

Tianjin Medical University Cancer Institute and Hospital

15 February 2024

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