Breast Reconstruction with TiLoop Bra Mesh
This study is looking at two ways to do breast reconstruction after a mastectomy (surgery to remove breast tissue) for breast cancer. One method uses a special mesh called TiLoop Bra along with a tissue expander (a temporary implant that stretches the skin). The other method uses only the tissue expander. Researchers want to see if using the TiLoop Bra mesh can lead to fewer complications, help the expander work better, and result in a nicer appearance. You might be able to join if you are a woman between 18 and 70 years old with breast cancer, good overall health, and no spread of cancer. The study aims to enroll 300 participants. The current status of the study is unclear.
- Study design
- This is a randomized study comparing two breast reconstruction methods, aiming to enroll 300 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for complication rates for up to 24 months after surgery, and for expansion efficiency for an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Breast Mesh Used in Two-staged Breast Reconstruction
At a glance
Conditions
Where it's being run
6 sites across 6 statesWho to contact
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What this trial measures
- Complication Ratesup to 24 months after surgery
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
- Expansion Efficiencythrough study completion, an average of 1 year
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year