Recruiting

Breast Mesh

Sponsor:

Tianjin Medical University Cancer Institute and Hospital

Code:

NCT04967976

Conditions

Breast Cancer

Radiation

Breast Reconstruction

Synthetic Mesh

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

TiLoop Bra mesh in expander-implant breast reconstrution

sub-pectoral expander-implant breast reconstruction

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Radiation

Breast Reconstruction

Synthetic Mesh

Study ID

NCT04967976

Start date

Aug 1, 2021

Status verified date

Apr, 2021

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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

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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

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Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Breast Reconstruction with breast mesh

The tissue expander-implant reconstruction with TiLoop Bra mesh.

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.

Interventions

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.

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.

Primary outcome measure

  • Complication Rates [ Time Frame: up to 24 months after surgery ]
  • Expansion Efficiency [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Jian Yin

+86-22-23340123yinjian@tjmuch.com

Bowen Ding

+86-22-23340123ding_x87@126.com

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Last update posted

Jul 20, 2021

Last verified

Apr, 2021

Keywords

  • breast cancer
  • breast reconstruction
  • radiation
  • synthetic mesh

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital on 2021-07-20.