Breast Mesh Used in Two-staged Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosed with breast cancer
More than 18 years old
Karnofsky Performance Status (KPS) larger than 80
No clinical or imaging evidence of distant metastasis
Disqualifiers
None
Trial design
Treatments tested in this trial
- TiLoop Bra mesh in expander-implant breast reconstrution
- sub-pectoral expander-implant breast reconstruction
Treatment groups
300 Participants
are divided into 2 treatment groupsLocations
6China
Gansu Provincial Cancer Hospital LanzhouGansu, China
Jilin Cancer Hospital Ch’ang-ch’unJilin, China
Tianjin Medical University Cancer Institute and Hospital300060, TianjinTianjin Municipality, China
Zhejiang Provincial People's Hospital HangzhouZhejiang, China
Sponsors and collaborators
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Source ClinicalTrials.gov