Regenn® Therapy System Safety Study
ConditionSurgical Wound
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorProgenerative Medical, Inc
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Instability (defined as angulation ≥ 5 degrees and/or translation ≥ 3mm on flexion/extension radiographs;
Osteophyte formation of facet joints or vertebral endplates;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Regenn® Negative Pressure Therapy System
DeviceControlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.
Prevena™ Incision Management System
DeviceControlled application of negative pressure (i.e., reduced atmospheric pressure or mild vacuum) to manage the wound environment.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Device-related Serious Adverse Event Rate
The device-related serious adverse event rate associated with the use of the investigational device and the comparator device. Wound complications requiring surgical intervention, such as wound dehiscence, will be the primary indicator of blood supply at the wound site, damage to the surrounding tissue, and progression of wound healing.
Time frame
Post-operative follow ups at 2-8 weeks and 3-6 months.Secondary outcomes
1
Post-operative Pain Profile
Post-operative pain will be assessed using the Numerical Rating Scale (NRS), a validated pain measurement scoring system with a pain rating scale of 0 - 10, where zero means "No pain" and 10 means "The worst pain imaginable"
Time frame
Post-operative up to the 3-6 month follow up visit.2
Adverse Events Related to the Investigational Device
The number and type of adverse events associated with the use of the investigational device. Assessment will include wound complications not requiring surgical intervention, device complications, medical complications and infections complications.
Time frame
Post-operative follow ups at approximately one month and three months.Other outcomes
1
Delayed Seroma Formation Rate
Delayed seroma formation will be assessed by ultrasound imaging during post-operative follow up visits.
Time frame
Post-operative follow up at 2-8 weeks (at the surgeon's discretion) and at 3-6 months (required).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov