Breast Mesh Used in Two-staged Breast Reconstruction
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Breast Reconstruction with breast mesh The tissue expander-implant reconstruction with TiLoop Bra mesh. |
Procedure: TiLoop Bra mesh in expander-implant breast reconstrution
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
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Active Comparator: Breast Reconstruction without breast mesh The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia. |
Procedure: sub-pectoral expander-implant breast reconstruction
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
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Outcome Measures
Primary Outcome Measures
- Complication Rates [up to 24 months after surgery]
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
- Expansion Efficiency [through study completion, an average of 1 year]
percentage of average injected saline volume to total volume (E=average volume/ total volume)through study completion, an average of 1 year
Secondary Outcome Measures
- number of revision surgery [from the completion of expander exchange up to 24 months after surgery]
To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,
- aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire [from the completion of expander exchange up to 24 months after surgery]
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.
- psychological evaluation by Breast-Q questionnaire [from the completion of expander exchange up to 24 months after surgery]
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
- total cost [from expander implation up to the completion of expander exchange,through study completion, an average of 1 year]
total cost in RMB per captia
- number of occurrence of deep venous thrombosis [from expander implation up to the completion of expander exchange, through study completion, an average of 1 year]
post-operative occurrence of deep venous thrombosis
- number of occurrence of non-surgical site infection [from expander implation up to the completion of expander exchange, through study completion, an average of 1 year]
post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with breast cancer
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More than 18 years old
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Karnofsky Performance Status (KPS) larger than 80
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No clinical or imaging evidence of distant metastasis
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BMI < 35kg/m2
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Patients with no or mild breast ptosis
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No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
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Mental Health Patient
Exclusion Criteria:
- 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
2 | Gansu Provincial Cancer Hospital | Lanzhou | Gansu | China | |
3 | Jilin Cancer Hospital | Ch'ang-ch'un | Jilin | China | |
4 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | 300060 |
5 | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China | |
6 | Technical University of Munich | Munich | Germany |
Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E20210210