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Breast Mesh Used in Two-staged Breast Reconstruction
Sponsor: Tianjin Medical University Cancer Institute and Hospital
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.
Official title: A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2021-08-01
Completion Date
2026-08-01
Last Updated
2021-07-20
Healthy Volunteers
No
Interventions
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.
Locations (6)
MD Anderson Cancer Center
Houston, Texas, United States
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Jilin Cancer Hospital
Ch’ang-ch’un, Jilin, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Technical University of Munich
Munich, Germany