Regenn® Therapy System Safety Study

Phase 1

Recruiting

• Conditions: Surgical Wound
• Interventions: Device: Regenn® Negative Pressure Therapy System; Device: Prevena™ Incision Management System

• Registration Number: NCT06259409
• Lead Sponsor: Progenerative Medical, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-14
• Study Start: 2024-10-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Regenn® Negative Pressure Therapy System	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.
Control Arm	Prevena™ Incision Management System	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 Measures

Name	Time	Method
Device-related Serious Adverse Event Rate	Post-operative follow ups at 2-8 weeks and 3-6 months.	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain Profile	Post-operative up to the 3-6 month follow up visit.	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"
Adverse Events Related to the Investigational Device	Post-operative follow ups at approximately one month and three months.	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.

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States