Clinical trial NCT06259409: Regenn® Therapy System Safety Study
Official title: A Randomized Clinical Study Evaluating the Safety of Regenn® Negative Pressure Therapy System in Orthopaedic Surgical Wound Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Surgical Wound
Lead sponsor: Progenerative Medical, Inc
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled investigational study
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Device-related Serious Adverse Event Rate
timeFrame: Post-operative follow ups at 2-8 weeks and 3-6 months.
Secondary outcomes:
measure: Post-operative Pain Profile
timeFrame: Post-operative up to the 3-6 month follow up visit.
measure: Adverse Events Related to the Investigational Device
timeFrame: Post-operative follow ups at approximately one month and three months.
Other outcomes:
measure: Delayed Seroma Formation Rate
timeFrame: Post-operative follow up at 2-8 weeks (at the surgeon's discretion) and at 3-6 months (required).
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
References: