A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
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.
Eligibility
- Age range
- 18–70 years
- Sex
- Female
- Healthy volunteers
- No
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, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function. 8. Mental Health Patient \- Exclusion Criteria: 1\. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage I…
Interventions
- ProcedureTiLoop 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.
- Proceduresub-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 CenterHouston, Texas
- Gansu Provincial Cancer HospitalLanzhou, Gansu
- Jilin Cancer HospitalCh’ang-ch’un, Jilin
- Tianjin Medical University Cancer Institute and HospitalTianjin, Tianjin Municipality
- Zhejiang Provincial People's HospitalHangzhou, Zhejiang
- Technical University of MunichMunich