RecruitingPhase 1NCT06259409

Regenn® Therapy System Safety Study

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


Sponsor

Progenerative Medical, Inc

Enrollment

30 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Prevena™ Incision Management System and a medical device called Regenn® Negative Pressure Therapy System for people with surgical wound. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERegenn® Negative Pressure Therapy System

Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.

DEVICEPrevena™ Incision Management System

Controlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.


Locations(1)

The University of Kansas Medical Center

Kansas City, Kansas, United States

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NCT06259409


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