NCT06259409

Regenn® Therapy System Safety Study

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Progenerative Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Wound

Interventions

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

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2024-02-14
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study