Pre-pectoral Breast Reconstruction With or Without Mesh

January 29, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Principal Investigator:
          • Jian Yin, MD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to 12 months after surgery
The rate of major complications in the two groups
up to 12 months after surgery
Patient Breast-Q questionnaire
Time Frame: up to 12 months after surgery
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
Time Frame: up to 12 months after surgery
To record the rate of surgical revision events of the reconstructed breasts
up to 12 months after surgery
Minor Complication Rates
Time Frame: up to 12 months after surgery
The rate of minor complications in the two groups
up to 12 months after surgery
Rates of capsule contracture
Time Frame: up to 24 months after surgery
The rates of capsule contracture in the two groups
up to 24 months after surgery
The rate of implant or tissue expander removal
Time Frame: up to 12 months after surgery
The rate of implant or tissue expander removal in the two groups
up to 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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