This clinical trial evaluates the Interi drain system compared to traditional surgical drains to improve surgical outcomes in breast cancer patients undergoing bilateral mastectomy and implant-based breast reconstruction. Conventional surgical drains, like the Jackson-Pratt drain, are made of a single piece of tubing connected to a bulb that creates suction. This suction pulls fluid away from the surgical site, allowing it to collect in the bulb rather than in the surgical area. Similarly, the Interi device uses suction to remove fluid, but this drain device uses a novel four-pronged branching manifold connected to a non-electric pump canister to improve the area of and amount of fluid drainage. This may reduce the risk of surgical complications in patients undergoing bilateral mastectomy surgery for breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05975359.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Dung H Nguyen
Phone: 650-492-9239
PRIMARY OBJECTIVE:
I. To demonstrate the Interi surgical drain system's superiority to Jackson Pratt (JP) drains within this population.
SECONDARY OBJECTIVE:
I. Demonstrate the Interi Surgical Drain System's superiority to standard JP drains.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care bilateral mastectomy surgery with the Interi drain system placed on the breast where the tumor is located, and the traditional surgical drain(s) placed on the side without the tumor. Patients log their drain output while they are in place and have them removed per standard of care.
ARM II: Patients undergo standard of care bilateral mastectomy surgery with the traditional surgical drain(s) placed on the breast where the tumor is located, and the Interi drain system placed on the side without the tumor. Patients log their drain output while they are in place and have them removed per standard of care.
After completion of study treatment, patients are followed up at 6 months and 1 year.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorDung H Nguyen
