Pre-pectoral Breast Reconstruction With or Without Mesh

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a type of breast reconstruction called pre-pectoral breast reconstruction, which means the implant is placed above the chest muscle. The goal is to see how the use of a special mesh called TiLOOP affects the outcome of this procedure compared to when the mesh is not used. Researchers want to find out if using the mesh can improve safety and recovery for patients who are having this surgery.

To be eligible for the trial, participants need to be women aged 18 to 65 who are planning to have breast reconstruction after a mastectomy due to breast cancer or for preventive reasons. They should have good blood flow to the breast area and must not have smoked in the last month. Participants will need to sign a consent form to take part in the study. If you join the trial, you can expect to receive care from the medical team as they monitor your recovery and any effects of using the TiLOOP mesh. This trial is currently looking for participants, so if you think you might qualify, it could be a good opportunity to contribute to important research in breast reconstruction.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
• • 2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
• • 3. Tissue expander size =\<800cc, implant size =\<600cc;
• • 4. The blood perfusion of breast skin flap was well;
• • 5. Do not smoking in the last 4 weeks or more
• • 6. Patients with normal expectations and mental health for breast reconstruction;
• • 7. Signed consent to participate
• Exclusion Criteria:
• • 1. Poor perfusion of breast mastectomy flap;
• • 2. II stage breast reconstruction patients;
• • 3. History of chest radiotherapy;
• • 4. BMI greater than 35;
• • 5. Patients who have not quit smoking within the last 4 weeks;