Regenn® Therapy System Safety Study

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Regenn® Negative Pressure Therapy System
  Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.
• Устройство Prevena™ Incision Management System
  Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.

Первичные конечные точки

• Device-related Serious Adverse Event Rate [Срок оценки: Post-operative follow ups at 2-8 weeks and 3-6 months.]

Вторичные конечные точки (2)

• Post-operative Pain Profile [Срок оценки: Post-operative up to the 3-6 month follow up visit.]
• Adverse Events Related to the Investigational Device [Срок оценки: Post-operative follow ups at approximately one month and three months.]

Критерии участия

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT06259409 · Doc-0353

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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