RecruitingNot ApplicableNCT04967976

Breast Mesh Used in Two-staged Breast Reconstruction

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


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

300 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether using a surgical mesh during the first stage of two-stage breast reconstruction after mastectomy leads to better outcomes for women with breast cancer. **You may be eligible if...** - You have been diagnosed with breast cancer and are planning a two-stage breast reconstruction - You are over 18 years old - You have good general health and performance status - You have no evidence of distant (spread) cancer - Your BMI is below 35 - You have minimal or no breast sagging - You have normal blood counts, heart, liver, and kidney function **You may NOT be eligible if...** - Your cancer has spread to other parts of the body, or you have a local recurrence - You have previously had radiation to the same breast or chest wall - You have inflammatory breast cancer or stage IV disease - You have severe allergies or a history of anaphylaxis - You are pregnant, breastfeeding, or planning pregnancy during the study - You have a mental illness or substance abuse problem Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETiLoop 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.

PROCEDUREsub-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.


Locations(6)

MD Anderson Cancer Center

Houston, Texas, United States

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Jilin Cancer Hospital

Ch’ang-ch’un, Jilin, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Technical University of Munich

Munich, Germany

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NCT04967976


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