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

Not Applicable

• Conditions: Implant Breast Reconstruction; Bovine Pericardial Patch; TiLOOP® Bra Mesh
• Interventions: Procedure: TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction; Procedure: Bovine Pericardial Patch in Immediate Implant Breast Reconstruction

• Registration Number: NCT04245930
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-02-05
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TiLOOP® Bra Mesh	TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction	Immediate implant breast reconstruction using TiLOOP® Bra Mesh. n=88
Bovine Pericardial Patch	Bovine Pericardial Patch in Immediate Implant Breast Reconstruction	Immediate implant breast reconstruction using bovine pericardial patch. n=88

Primary Outcome Measures

Name	Time	Method
Complication Rates	up to 12 months after surgery	The rate of complications in the two groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China