Pre-pectoral Breast Reconstruction With or Without Mesh

A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh

To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

Study Overview

• Status: Recruiting
• Conditions: Prepectoral Breast Reconstruction; TiLOOP Mesh
• Intervention / Treatment: Procedure: prepectoral breast reconstruction; Procedure: Tiloop Mesh implantation

Detailed Description

The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Yin; Phone Number: 1171 +86-22-23340123; Email: yinjian@tjmuch.com
• Study Contact Backup: Name: Chunyong Han; Phone Number: 1171 +86-22-23340123; Email: hancy_007@126.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: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
3. Tissue expander size =<800cc, implant size =<600cc;
4. The blood perfusion of breast skin flap was well;
5. Do not smoking in the last 4 weeks or more
6. Patients with normal expectations and mental health for breast reconstruction;
7. Signed consent to participate

Exclusion Criteria:

1. Poor perfusion of breast mastectomy flap;
2. II stage breast reconstruction patients;
3. History of chest radiotherapy;
4. BMI greater than 35;
5. Patients who have not quit smoking within the last 4 weeks;

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: prepectoral breast reconstruction with Mesh; Immediate prepectoral breast reconstruction with Mesh	Procedure: prepectoral breast reconstruction; Patients receive immediate prepectoral breast reconstruction; Procedure: Tiloop Mesh implantation; Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Experimental: prepectoral breast reconstruction without Mesh; Immediate prepectoral breast reconstruction without Mesh	Procedure: prepectoral breast reconstruction; Patients receive immediate prepectoral breast reconstruction

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
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
Minor Complication Rates	The rate of minor complications in the two groups	up to 12 months after surgery
Rates of capsule contracture	The rates of capsule contracture in the two groups	up to 24 months after surgery
The rate of implant or tissue expander removal	The rate of implant or tissue expander removal in the two groups	up to 12 months after surgery

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: E20230013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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