Breast Cancer, Breast Reconstruction, Radiation, Synthetic Mesh
Conditions
Keywords
breast cancer, breast reconstruction, radiation, synthetic mesh
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.
Interventions
PROCEDURETiLoop 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.
PROCEDUREsub-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.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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, |
| 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. |
| 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 |
| 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. |
Countries
China, Germany, United States
Contacts
Primary ContactJian Yin
Backup ContactBowen Ding
Outcome results
None listed