1. Complication Rates (Time Frame - 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.
2. Expansion Efficiency (Time Frame - 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:
1. number of revision surgery (Time Frame - 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,
2. aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire (Time Frame - 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.
3. psychological evaluation by Breast-Q questionnaire (Time Frame - 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.
4. total cost (Time Frame - from expander implation up to the completion of expander exchange,through study completion, an average of 1 year): total cost in RMB per captia
5. number of 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): post-operative occurrence of deep venous thrombosis
6. number of occurrence of non-surgical site infection (Time Frame - 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.
Experimental: Breast Reconstruction with breast mesh The tissue expander-implant reconstruction with TiLoop Bra mesh.
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.
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.
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.
Quelle: ClinicalTrials.gov
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