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

Implant Breast Reconstruction Clinical Trial

Official title:

A Randomized and Controlled Study of Efficacy and Safety of Bovine Pericardial Patch and TiLOOP® Bra Mesh in Patients With Immediate Implant Breast Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04245930
• Other study ID #: E2019453
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Chunyong Han, MD.
• Phone: +86-22-23340123
• Email: hancy_007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bovine Pericardial Patch
• Implant Breast Reconstruction
• TiLOOP® Bra Mesh

Intervention

Procedure:
• Bovine Pericardial Patch in Immediate Implant Breast Reconstruction
Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch
• TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction
Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rates	The rate of complications in the two groups	up to 12 months after surgery
Secondary	Patient satisfaction-Breast-Q questionnaire	We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.	up to 12 months after surgery
Secondary	Cosmetic outcome of reconstructed breast	Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".	Immediately, up to 3 months, 6 months and 12 months after surgery
Secondary	The rate of surgical revision of reconstructed breasts	To record the rate of surgical revision events of the reconstructed breasts	up to 12 months after surgery
Secondary	Health economics-inpatient cost	Hospital inpatient costs due to immediate implant breast reconstruction	up to 12 months after surgery, including the cost of surgical revision