A Randomized Clinical Study Evaluating the Safety of Regenn4 Negative Pressure Therapy System in Orthopaedic Surgical Wound Management

What this Trial Is About

Researchers are evaluating the safety of the Regenn4 Negative Pressure Therapy System, a device designed to manage post-operative surgical wounds in patients undergoing lumbar spinal fusion surgeries. This study focuses on measuring the rate of device-related serious adverse events, patient post-operative pain, the number and types of adverse events, and the occurrence of delayed seroma formation. The study is a randomized, phase 1 clinical trial comparing Regenn4 Therapy to an existing negative pressure wound therapy device. Participants will be randomly assigned to receive either the Regenn4 Negative Pressure Therapy System or the Prevena12 Incision Management System. Both devices apply controlled negative pressure a mild vacuum to the surgical wound to support healing. The therapy is delivered via a small, battery-operated pump connected to a dressing placed in or over the surgical wound at the end of surgery. The devices are used during the post-operative recovery period. Participants will be screened for eligibility, complete informed consent, and undergo physical exams, vital sign assessments, and blood tests before enrollment. They will attend two follow-up visits approximately one month and three months after surgery to monitor adverse events and assess pain using validated scoring systems. Researchers will carefully track device-related serious adverse events during follow-ups at 2-8 weeks and 3-6 months post-operation to evaluate safety and patient experience over time.

Regenn® Therapy System Safety Study