regenn® therapy system safety study

Conditions: Surgical Wound

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 criteria:
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 flexion/extension radiographs; * osteophyte formation of facet joints or vertebral endplates; * decreased disc height, on average by \>2mm, but dependent upon the spinal level; * scarring / thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule; * herniated nucleus pulposus; * facet joint degeneration / changes; and/or * vacuum phenomenon. * female subjects of childbearing potential must not be pregnant or nursing and must agree to use of contraception for the study duration. female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test and birth control. * the subject is willing and able to comply with the protocol mandated follow-up visits and testing regimen. exclusion criteria (candidates meeting any of the following at the time of the study procedure are not eligible): * subject is unable or unwilling to provide informed consent or is unable to conform to the study protocol follow-up procedures and visits. * subject has a contraindication (including allergic reaction) to antiplatelet/anticoagulant medications, nickel, titanium, bone allograft, or blood transfusion that is not amenable to pretreatment with steroids or/and antihistamines. * subject has a history of bleeding diatheses or coagulopathy. * subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (sle), or any autoimmune diseases. * subject is receiving dialysis or immunosuppressive therapy. * subject suffered a hemorrhagic stroke \< 6 months prior to the study procedure. * subject is undergoing spinal surgery for vertebral fracture, trauma, or scoliosis. * subject has any form of active malignancy. * subject is an intravenous drug user and/or alcoholic. * subject is diagnosed with septicemia at the time of the study procedure. * subject is a smoker. * subject has type i diabetes. * subject has overt, uncontrolled type ii diabetes. * subject has a condition requiring postoperative medications that would be expected to interfere with fusion (e.g., steroids), or has received drugs that interfere with bone metabolism within 2 weeks of the surgery. * subject is suffering from gross obesity, defined as \> 40% ibw. * subject exhibits waddell signs of inorganic behavior ≥ 3. * subject has had a previous, anterior spinal fusion, interbody spinal fusion, or posterior spinal instrumentation at the involved level. * subject has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years. * subject has a systemic disease of connective tissue such as rheumatoid arthritis, or ankylosing spondylitis. * subject is a prisoner. * subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. (note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).