NCT04967976

Breast Mesh Used in Two-staged Breast Reconstruction

A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Radiation
• Breast Reconstruction
• Synthetic Mesh

Interventions

Type	Name	Description
PROCEDURE	TiLoop 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.
PROCEDURE	sub-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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-08-01
• Completion: 2026-08-01
• First posted: 2021-07-20
• Last updated: 2021-07-20

Locations

6 sites across 3 countries: United States, China, Germany