Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

Launched by STANFORD UNIVERSITY · Jul 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Interi Drain system, which is designed to improve the management of fluid after breast surgery. When women with breast cancer have surgery to remove their breasts (mastectomy) and choose to have implants placed at the same time (called implant-based breast reconstruction), they typically need a surgical drain to help prevent fluid build-up. The standard drain used is called a Jackson-Pratt (JP) drain, but it has some limitations. The Interi Drain system is a newer option that aims to provide better suction and cover more area, potentially leading to fewer complications and a shorter recovery time.

Eligible participants for this trial include women aged 18 to 65 who have been diagnosed with breast cancer and are planning to undergo a bilateral mastectomy with immediate implant-based reconstruction. They should be able to understand the information about the study and voluntarily agree to participate. If chosen to be part of the study, participants can expect to have their experiences compared with those using the standard JP drain, looking at factors like how many drains are needed, recovery times, and overall satisfaction with their care. This trial is currently recruiting participants who meet the criteria, and it could help improve future care for women undergoing similar surgeries.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
• • 2. Indication for bilateral mastectomy
• • 3. Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
• • 4. Age 18 - 65
• • 5. Female Sex
• • 6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).
• Exclusion Criteria:
• • 1. Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
• • 2. Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.
• • 3. Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days.
• • 4. Are a smoker or use illicit drugs.
• • 5. Any prior allergic reaction to Teflon.
• • 6. Are pregnant or nursing.
• • 7. Are undergoing a delayed reconstruction following mastectomy.
• • 8. HIV infection, active UTI infection, or other active infection.
• • 9. Those requiring more than one Manifold for fluid removal per breast will be excluded.