Actively Recruiting
A Randomized Clinical Study Evaluating the Safety of Regenn4 Negative Pressure Therapy System in Orthopaedic Surgical Wound Management
Led by Progenerative Medical, Inc · Updated on 2025-09-15
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Regenn® Therapy System Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has provided written informed consent approved by the Institutional Review Board.
- Subject is between 18 and 80 years old.
- Subject has Spondylolisthesis Grade II or less or Degenerative Disc Disease with back pain between L1 and S1 confirmed by history and imaging.
- Female subjects of childbearing potential are not pregnant or nursing and agree to use contraception during the study; surgically sterile or post-menopausal females are exempt from pregnancy testing and birth control.
- Subject is willing and able to comply with follow-up visits and testing.
You will not qualify if you...
- Subject is unable or unwilling to provide informed consent or comply with study follow-up.
- Subject has allergies or contraindications to antiplatelet/anticoagulant medications, nickel, titanium, bone allograft, or blood transfusion that cannot be managed.
- Subject has a history of bleeding disorders or coagulopathy.
- Subject has liver insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus, or autoimmune diseases.
- Subject is on dialysis or immunosuppressive therapy.
- Subject had a hemorrhagic stroke within 6 months prior to surgery.
- Subject is undergoing spinal surgery for fracture, trauma, or scoliosis.
- Subject has active cancer.
- Subject is an intravenous drug user or alcoholic.
- Subject has septicemia at surgery time.
- Subject is a smoker.
- Subject has Type I diabetes or uncontrolled Type II diabetes.
- Subject requires postoperative medications interfering with bone fusion or used such drugs within 2 weeks of surgery.
- Subject has gross obesity (>40% ideal body weight).
- Subject shows signs of inorganic behavior (Waddell signs >=3).
- Subject had previous spinal fusion or instrumentation at the involved level.
- Subject has another medical condition limiting protocol compliance or life expectancy below two years.
- Subject has connective tissue diseases like Rheumatoid Arthritis or Ankylosing Spondylitis.
- Subject is a prisoner.
- Subject is in another investigational drug or device trial that conflicts with this study endpoints.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until wound closure or up to several days post-surgery
Participants undergo surgery during which a wound dressing with a negative pressure therapy device is applied to manage the surgical wound while they recover.
1 surgery visit and device application
Duration - 2 to 8 weeks and 3 to 6 months post-surgery
Participants are monitored after surgery to assess device safety and wound healing, including post-operative pain and adverse events related to the device.
Post-operative visits at approximately 1 month, 2-8 weeks, and 3-6 months
Trial Site Locations
Total: 1 location
1
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
N
Neal K Vail, PhD
J
James W Poser, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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