Breast Mesh Used in Two-staged Breast Reconstruction

July 19, 2021 updated by: Tianjin Medical University Cancer Institute and Hospital

A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

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
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Suisheng Yang
    • Jilin
      • Ch'ang-ch'un, Jilin, China
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
          • Guiying Xu
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Principal Investigator:
          • Jian Yin
        • Contact:
        • Sub-Investigator:
          • Bowen Ding
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
  • Germany
      • Munich, Germany
        • Recruiting
        • Technical University of Munich
        • Contact:
          • Stefan Paepke
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
          • Edward Chang

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Diagnosed with breast cancer
  2. More than 18 years old
  3. Karnofsky Performance Status (KPS) larger than 80
  4. No clinical or imaging evidence of distant metastasis
  5. BMI < 35kg/m2
  6. Patients with no or mild breast ptosis
  7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

  8. Mental Health Patient

    -

    Exclusion Criteria:

1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

-

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breast Reconstruction with breast mesh
The tissue expander-implant reconstruction with TiLoop Bra mesh.
Procedure: TiLoop Bra mesh in expander-implant breast reconstrution
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
Active Comparator: Breast Reconstruction without breast mesh
The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Procedure: sub-pectoral expander-implant breast reconstruction
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rates
Time Frame: up to 24 months after surgery
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
up to 24 months after surgery
Expansion Efficiency
Time Frame: through study completion, an average of 1 year
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of revision surgery
Time Frame: from the completion of expander exchange up to 24 months after surgery
To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,
from the completion of expander exchange up to 24 months after surgery
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
Time Frame: from the completion of expander exchange up to 24 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".

Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.
from the completion of expander exchange up to 24 months after surgery
psychological evaluation by Breast-Q questionnaire
Time Frame: from the completion of expander exchange up to 24 months after surgery
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
from the completion of expander exchange up to 24 months after surgery
total cost
Time Frame: from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
total cost in RMB per captia
from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
number of occurrence of deep venous thrombosis
Time Frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
post-operative occurrence of deep venous thrombosis
from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
number of occurrence of non-surgical site infection
Time Frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.
from expander implation up to the completion of expander exchange, through study completion, an average of 1 year

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 (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

July 19, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20210210

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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