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

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

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

Study Overview

• Status: Recruiting
• Conditions: Implant Breast Reconstruction; TiLOOP® Bra Mesh; Bovine Pericardial Patch
• Intervention / Treatment: Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction; Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunyong Han, MD.; Phone Number: 1174 +86-22-23340123; Email: hancy_007@126.com
• Study Contact Backup: Name: Jian Yin, MD.; Phone Number: 1171 +86-22-23340123; Email: yinjian@tjmuch.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Chunyong Han, MD.; Phone Number: 1174 +86-22-23340123; Email: hancy_007@126.com
      • Principal Investigator: Jian Yin, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bovine Pericardial Patch; Immediate implant breast reconstruction using bovine pericardial patch. n=88	Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction; Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch
Experimental: TiLOOP® Bra Mesh; Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88	Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction; Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rates	The rate of complications in the two groups	up to 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Jian Yin, MD., Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: E2019453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No