Prevena Spine for Use in Spine Surgery

A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery

A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Incision, Surgical
• Intervention / Treatment: Procedure: Spine surgery; Device: Prevena Plus 125 Therapy Unit

Detailed Description

The objective of the study is to evaluate the efficacy of the Prevena Plus 125 therapy Unit (KCI USA, Inc.) in preventing surgical site infections and other wound complications in patients undergoing spine surgery compared to conventional wound dressing. Furthermore, the investigators want to illustrate which patients benefit most significantly from Prevena usage as spine surgery sees a range of potential candidates, and not all may experience equivalent recovery from spine surgery with Prevena intervention.

• Study Type: Interventional
• Enrollment (Estimated): 285
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robert Galiano, MD; Phone Number: 312-695-6022; Email: robert.galiano@nm.org
• Study Contact Backup: Name: Tokoya Williams, MD; Phone Number: 3126955667; Email: tokoya.williams@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital
      • Contact: Robert Galiano, MD; Phone Number: 312-695-6022; Email: robert.galiano@nm.org
      • Principal Investigator: Robert Galiano, MD
      • Contact: Kristin Huffman, BS; Phone Number: 3129267037; Email: kristin.huffman@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients undergoing spine surgery that requires closure by plastic surgeon
2. Over 18 years old
3. Risk Score Cutoff 80+
4. (Control) Matched to a prospective research participant

Exclusion Criteria:

1. Risk Score Cutoff <80
2. Medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the subject inappropriate for entry into this study
3. Subjects who are pregnant at the date of surgery (SOC for surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1 (control); Retrospective control of patients who did not use Prevena following spine surgery.	Procedure: Spine surgery; Patients will receive spine surgery
Active Comparator: Group 2 (Prevena); Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.	Procedure: Spine surgery; Patients will receive spine surgery; Device: Prevena Plus 125 Therapy Unit; The investigators will utilize the KCI USA, Inc Prevena Plus 125 vacuum-assisted closure device in patients undergoing spine surgery as a method to prevent surgical site infections and wound dehiscence after surgery. The device has been approved by the FDA under the name "Prevena 125 and Prevena Plus 125 Therapy Units" and regulation number 21CFR 878.4783.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Surgical site infections	Determine if infection is present at surgical site or not.	1-6 weeks following surgery
Frequency of Wound dehiscence	Determine if wound reopening (dehiscence) is present at surgical site or not.	1-6 weeks following surgery
Frequency of Seroma	Determine if seromas (collection of fluid under the skin) are present at surgical site or not.	1-6 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of skin necrosis	Measure the frequency of patients who experience skin necrosis in the incision area	1-6 weeks following surgery
Frequency of readmission	Measure the frequency of patients who are readmitted following surgery	1-6 weeks following surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: 3M

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: spine surgery; negative pressure wound therapy; incisional wound therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: STU00216293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes