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

Breast Cancer Radiation Breast Reconstruction Synthetic Mesh

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

Inclusion Criteria9

Diagnosed with breast cancer
More than 18 years old
Karnofsky Performance Status (KPS) larger than 80
No clinical or imaging evidence of distant metastasis
BMI \< 35kg/m2
Patients with no or mild breast ptosis
No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
Mental Health Patient
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Exclusion Criteria2

\. 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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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.