Bovine Pericardial Patch and TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction.

Tianjin Medical University

Status: Unknown

Conditions: Implant Breast Reconstruction; Bovine Pericardial Patch; TiLOOP® Bra Mesh

Treatments: Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction; Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04245930

E2019453

Details and patient eligibility

About

This study is the first randomized and controlled study assessing the efficacy and safety of bovine pericardial patch and TiLOOP® bra mesh in patients with immediate implant breast reconstruction

Enrollment: 176 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with I~II stage breast cancer and Intent to receive NSM or SSM and implant based breast reconstruction
2. Do not smoking in the last 4 weeks or more
3. Mental health patients
4. Signed consent to participate

Exclusion criteria

1. Locally advanced stage patients or patients with distal metastasis
2. Patients received thoracic wall radiotherapy or will receive radiotherapy
3. Smoking in the last 4 weeks
4. Anticipated implant volume more than 600cc
5. Patients of pregnancy or lactation
6. Patients received neoadjuvant therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Bovine Pericardial Patch

Active Comparator group

Description:

Immediate implant breast reconstruction using bovine pericardial patch. n=88

Treatment:

Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction

TiLOOP® Bra Mesh

Experimental group

Description:

Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88

Treatment:

Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction