Breast Cancer Clinical Trial
Official title:
A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | August 1, 2026 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
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 - 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 - |
Country | Name | City | State |
---|---|---|---|
China | Jilin Cancer Hospital | Ch'ang-ch'un | Jilin |
China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
China | Gansu Provincial Cancer Hospital | Lanzhou | Gansu |
China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
Germany | Technical University of Munich | Munich | |
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
United States, China, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complication Rates | complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc. | up to 24 months after surgery | |
Primary | Expansion Efficiency | percentage of average injected saline volume to total volume (E=average volume/ total volume)through study completion, an average of 1 year | through study completion, an average of 1 year | |
Secondary | number of revision surgery | To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation, | from the completion of expander exchange up to 24 months after surgery | |
Secondary | aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire | Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".
Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast. |
from the completion of expander exchange up to 24 months after surgery | |
Secondary | psychological evaluation by Breast-Q questionnaire | We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q. | from the completion of expander exchange up to 24 months after surgery | |
Secondary | total cost | total cost in RMB per captia | from expander implation up to the completion of expander exchange,through study completion, an average of 1 year | |
Secondary | number of occurrence of deep venous thrombosis | post-operative occurrence of deep venous thrombosis | from expander implation up to the completion of expander exchange, through study completion, an average of 1 year | |
Secondary | number of occurrence of non-surgical site infection | post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc. | from expander implation up to the completion of expander exchange, through study completion, an average of 1 year |
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