Breast Mesh Used in Two-staged Breast Reconstruction

Tianjin Medical University

Status: Enrolling

Conditions: Breast Reconstruction; Breast Cancer; Synthetic Mesh; Radiation

Treatments: Procedure: sub-pectoral expander-implant breast reconstruction; Procedure: TiLoop Bra mesh in expander-implant breast reconstrution

Study type: Interventional

Funder types: Other

Identifiers

NCT04967976

E20210210

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

9. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Breast Reconstruction with breast mesh

Experimental group

Description:

The tissue expander-implant reconstruction with TiLoop Bra mesh.

Treatment:

Procedure: TiLoop Bra mesh in expander-implant breast reconstrution

Breast Reconstruction without breast mesh

Active Comparator group

Description:

The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Treatment:

Procedure: sub-pectoral expander-implant breast reconstruction