Prevena Spine for Use in Spine Surgery

NCT05555355 | Completed Phase 4 FDA Device

• 1 other identifier: STU00216293
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgery; Incision, Surgical

Keywords

negative pressure wound therapy; incisional wound therapy; spine surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Frequency of skin necrosis

  1-6 weeks following surgery

• Frequency of readmission

  1-6 weeks following surgery

Study Arms (2)

Group 1 (control)

PLACEBO COMPARATOR

Prospective control of patients who did not use Prevena following spine surgery.

Procedure: Spine surgery

Group 2 (Prevena)

ACTIVE COMPARATOR

Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.

Device: Prevena Plus 125 Therapy Unit; Procedure: Spine surgery

Interventions

Prevena Plus 125 Therapy Unit DEVICE

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.

Group 2 (Prevena)

Spine surgery PROCEDURE

Patients will receive spine surgery

Group 1 (control); Group 2 (Prevena)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing spinal fusion surgery
• Over 18 years old

You may not qualify if:

• 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 judgment of the Investigator, would make the subject inappropriate for entry into this study
• Subjects who are pregnant at the date of surgery (SOC for surgery)

Sponsors & Collaborators

• 3M: collaborator
• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: Single center study

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: September 26, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)