Regenn® Therapy System Safety Study

Surgical Wound Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Surgical Wound

• NCT number: NCT06259409
• Study type: Interventional
• Source: Progenerative Medical, Inc
• Contact: Neal K Vail, PhD
• Phone: (844) 977-6436
• Email: clinical@progenerative.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 2024
• Completion date: May 2025