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A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP Bra Mesh in Patients With Expander-Implant Breast Reconstruction
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2021-07-20
300
Participants Needed
6
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of TiLOOP4 Bra mesh in patients undergoing expander-implant breast reconstruction after breast cancer surgery. This is the first prospective randomized and controlled study designed to assess the safety and effectiveness of incorporating TiLOOP Bra mesh with tissue expanders. The goal is to see if this mesh can reduce capsular contracture rates, improve the efficiency of tissue expansion, and provide better aesthetic results compared to reconstruction without mesh. Participants will be randomly assigned to one of two groups: one receiving tissue expander-implant reconstruction with TiLOOP Bra mesh placed sub-pectorally immediately after nipple or skin-sparing mastectomy, and the other receiving tissue expander-implant reconstruction without the mesh, where the expander is placed sub-pectorally and covered by muscle or fascia. The study includes a triple masking design to reduce bias. During the study, participants will be monitored for complications up to 24 months post-surgery and for expansion efficiency over about one year. Additional assessments include the number of revision surgeries, aesthetic outcomes evaluated by the Harris score and Breast-Q questionnaire, psychological evaluations, total treatment cost, and occurrences of deep venous thrombosis or infections. The study spans from tissue expander implantation through expander exchange and follow-up, with careful safety and outcome monitoring throughout.
CONDITIONS
Brief Title
Breast Mesh Used in Two-staged Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with breast cancer
- Age more than 18 years and up to 70 years
- Karnofsky Performance Status (KPS) larger than 80
- No clinical or imaging evidence of distant metastasis
- Body mass index (BMI) less than 35 kg/m2
- Patients with no or mild breast sagging (ptosis)
- No severe deficiency in blood, heart, immune system, liver, or kidney function
- Mental health patient
You will not qualify if you...
- Patients with distant metastasis of breast cancer or local recurrence
- Past radiation treatment to the same breast or chest wall
- Inflammatory breast cancer or stage IV breast cancer
- History of severe allergies or specific medical conditions
- Mental illness
- Drug or alcohol abuse
- Pregnancy, breastfeeding, or becoming pregnant during the trial
- Deemed ineligible by researchers based on study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and hospital stay period
Participants undergo two-staged breast reconstruction surgery with or without TiLoop Bra mesh immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectorally during the first stage of reconstruction.
1 surgical visit and immediate post-operative hospital care
Duration - Up to 24 months after surgery
Participants are followed up to monitor complication rates, expansion efficiency, and other outcomes after surgery and expander implantation.
Approximately monthly visits during the first year and less frequent visits thereafter up to 24 months
Trial Site Locations
Total: 6 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
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2
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
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3
Jilin Cancer Hospital
Ch’ang-ch’un, Jilin, China
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4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
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5
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
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6
Technical University of Munich
Munich, Germany
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Research Team
J
Jian Yin
B
Bowen Ding
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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