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NCT04967976NARecruiting

Breast Mesh Used in Two-staged Breast Reconstruction

Tianjin Medical University Cancer Institute and Hospital

Start Date

8/1/2021

Completion Date

8/1/2026

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 Criteria

Age Range: 18 years to 70 years

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 \- 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 \-

Interventions

PROCEDURE

TiLoop Bra mesh in expander-implant breast reconstrution

PROCEDURE

sub-pectoral expander-implant breast reconstruction

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Conditions

Breast CancerRadiationBreast ReconstructionSynthetic Mesh

Locations

MD Anderson Cancer Center

Houston, Texas 77030

United States

Gansu Provincial Cancer Hospital

Lanzhou, Gansu

China

Jilin Cancer Hospital

Ch’ang-ch’un, Jilin

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang

China

Technical University of Munich

Munich,

Germany