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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
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.
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.
MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
RECRUITINGJilin Cancer Hospital
Ch’ang-ch’un, Jilin, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGZhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGTechnical University of Munich
Munich, Germany
RECRUITINGComplication Rates
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Time frame: 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
Time frame: through study completion, an average of 1 year
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,
Time frame: 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.
Time frame: 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.
Time frame: from the completion of expander exchange up to 24 months after surgery
total cost
total cost in RMB per captia
Time frame: 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
Time frame: 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.
Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
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