A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management
Progenerative Medical, Inc
Summary
The goal of this clinical trial is to evaluate the safety of the investigational device, Regenn® Negative Pressure Therapy System (Regenn® Therapy), a form of Negative Pressure Wound Therapy (NPWT), in the post-operative surgical wounds of patients undergoing lumbar spinal fusion surgeries. The main questions the study aims to answer are: * The device-related serious adverse event rate. * Patient post-operative pain as assessed using a validated pain measurement scoring system. * The number and type of adverse events. * The rate of delayed seroma formation. Participants will * Be screened for their suitability to participate in the investigational study using questions about their health, medical history, and current medications. * Undergo a physical exam, an assessment of patient vital signs and routine blood analyses. * Complete an Informed Consent Form if selected to participate in the investigational study. * Be randomly assigned to the different study arms. * Not change the operation of their respective device or to disturb components of their device. * Notify their surgeon or designated healthcare provider should they have any questions or encounter any issues with their device. * Attend two post-operative visits at approximately one month and three months.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria (must meet ALL): * Subject has provided written informed consent on a form reviewed and approved by the Institutional Review Board for the clinical site. * The subject is 18 - 80 years old. * The subject has Spondylolisthesis of Meyerding Grade II or less, or has Degenerative Disc Disease (DDD) accompanied by back pain with or without leg pain at a level between L1 and S1 confirmed by history and radiographic assessment. DDD is determined to be present if one or more of the following are noted: * Instability (defined as angulation ≥ 5 degrees and/or translation ≥ 3mm on…
Interventions
- DeviceRegenn® Negative Pressure Therapy System
Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.
- DevicePrevena™ Incision Management System
Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.
Location
- The University of Kansas Medical CenterKansas City, Kansas