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
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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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Interventions
PROCEDURE
TiLoop Bra mesh in expander-implant breast reconstrution
PROCEDURE
sub-pectoral expander-implant breast reconstruction
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