Breast Mesh Used in Two-staged Breast Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

Conditions
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Breast Cancer, Radiation, Breast Reconstruction, Synthetic Mesh

Intervention / Treatment
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* Procedure: TiLoop Bra mesh in expander-implant breast reconstrution
* Procedure: sub-pectoral expander-implant breast reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with breast cancer More than 18 years old Karnofsky Performance Status (KPS) larger than 80 No clinical or imaging evidence of distant metastasis BMI < 35kg/m2 Patients with no or mild breast ptosis No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function. 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Reconstruction with breast mesh<br>The tissue expander-implant reconstruction with TiLoop Bra mesh. | Procedure: TiLoop Bra mesh in expander-implant breast reconstrution<br>* 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.<br>|
| Active Comparator: Breast Reconstruction without breast mesh<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, breast reconstruction, radiation, synthetic mesh