Breast Mesh Used in Two-staged Breast Reconstruction
Recruiting
N/A
Interventional Study
Breast Cancer
Radiation
Breast Reconstruction
Synthetic Mesh
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital · Other
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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.
Trial Locations
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Eligibility Criteria
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, cardiovas…
Contacts