Breast Mesh Used in Two-staged Breast Reconstruction

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Jul 19, 2021

Keywords

ClinConnect Summary

This clinical trial is designed to study the use of a special mesh called TiLOOP® Bra in women who are undergoing breast reconstruction after being treated for breast cancer. The researchers want to find out if using this mesh with tissue expanders (devices that help create space for breast implants) can reduce complications like capsular contraction (which can make the breast feel hard) and improve the overall appearance of the reconstructed breast.

To participate in this trial, women must be at least 18 years old, have been diagnosed with breast cancer, and have a good level of health without serious medical issues. They should not have any signs of cancer spreading to other parts of the body and should have a body mass index (BMI) under 35. Participants can expect to be randomly assigned to receive either the mesh or standard care and will be monitored throughout the process to see how well the reconstruction goes and any side effects. This study is currently recruiting, so if you meet the criteria and are interested, you might consider discussing it with your healthcare provider.

Gender

FEMALE

Eligibility 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
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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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