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Breast Mesh Used in Two-staged Breast Reconstruction

RECRUITINGN/ASponsored by Tianjin Medical University Cancer Institute and Hospital
Actively Recruiting
PhaseN/A
SponsorTianjin Medical University Cancer Institute and Hospital
Started2021-08-01
Est. completion2023-08-01
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Age: 18 Years – 70 YearsSex: FEMALEHealthy volunteers accepted
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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Conditions5

Breast CancerBreast ReconstructionCancerRadiationSynthetic Mesh

Locations1 site

MD Anderson Cancer Center
Houston, Texas, 77030
Edward Chang

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