A Pilot Study Comparing the Interi Manifold and Traditional Surgical Drains in Implant-Based Breast Reconstruction

What this Trial Is About

This research aims to compare two surgical drain systems used in patients undergoing implant-based breast reconstruction after mastectomy for breast cancer or genetic risk. The study evaluates the Interi Manifold Drain System, a novel device designed to provide consistent suction and improved fluid management, against the commonly used Jackson Pratt drain. The goal is to assess differences in outcomes such as complication rates, number of drain sites, time to drain removal, fluid volume drained, initiation of tissue expansion, and patient satisfaction. Participants will have bilateral mastectomy followed by immediate implant-based breast reconstruction with a tissue expander. Each breast will be randomly assigned to receive either the Interi manifold drain or the Jackson Pratt drain during surgery. Both drains will remain in place until the output is low enough for removal, typically between 1 and 3 weeks after surgery. Patients will monitor their drain output daily and keep logs while drains are in place. Postoperative follow-ups will occur weekly until drain removal and then monthly as part of routine care, including tissue expansion preparation. Throughout the study, researchers will collect clinical data from weekly follow-ups, monitor complications until the second stage surgery (implant exchange), and assess patient satisfaction using questionnaires at several post-op time points. The total fluid drained and timing of tissue expansion will also be recorded. Safety and device performance will be closely monitored, with participation lasting through the initial surgery and follow-up phases, typically up to six months for key outcome assessments.

Assessment of the Interi Manifold in Implant-Based Breast Reconstruction