Regenn® Therapy System Safety Study

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Progenerative Medical, Inc
Study ID
NCT06259409
Phase
PHASE1
Status
Recruiting
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Conditions

  • Surgical Wound

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 9, 2024
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    This group will receive the study device, Regenn® Negative Pressure Therapy System, a form of Negative Pressure Wound Therapy (NPWT). Regenn® Therapy manages the surgical wound by the application of reduced pressure therapy (i.e., mild vacuum). Reduced pressure therapy is controlled by a hand-sized, battery-operated pump and is delivered by an attached small, dressing that the surgeon places in the surgical wound at the end of the surgery. Reduced pressure therapy is applied while the patient recovers from surgery.
  • Active Comparator: Control Arm
    This group will receive the control device, also a form of Negative Pressure Wound Therapy (NPWT), which manages the surgical wound by the application of reduced pressure therapy (i.e., mild vacuum). Reduced pressure therapy is controlled by a hand-sized, battery-operated pump and is delivered by a small tube connected to a wound dressing placed over the closed surgical wound at the end of the surgery. Reduced pressure therapy is applied while the patient recovers from surgery.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Kansas Medical CenterKansas CityKansas66160
Sharon Bradshaw
[email protected]

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By research site
The University of Kansas Medical Center· Kansas City, KS

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