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Breast Mesh Used in Two-staged Breast Reconstruction

Breast Mesh Used in Two-staged Breast Reconstruction

Recruiting
18-70 years
Female
Phase N/A

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Overview

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

Eligibility

Inclusion Criteria:

  1. Diagnosed with breast cancer
  2. More than 18 years old
  3. Karnofsky Performance Status (KPS) larger than 80
  4. No clinical or imaging evidence of distant metastasis
  5. BMI < 35kg/m2
  6. Patients with no or mild breast ptosis
  7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
  8. Mental Health Patient

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    Exclusion Criteria:

    1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

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Study details
    Breast Cancer
    Radiation
    Breast Reconstruction
    Synthetic Mesh

NCT04967976

Tianjin Medical University Cancer Institute and Hospital

25 January 2024

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