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Completed

NCT Number: NCT05555355

Prevena Spine for Use in 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.

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Key information

Conditions

Surgery Incision, Surgical Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing spinal fusion surgery
  • Over 18 years old

Exclusion criteria

  • 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)

Treatment and study plan

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.

Spine surgery

Procedure

Patients will receive spine surgery

Primary outcomes

  1. Frequency of Surgical site infections

    Time frame: 1-6 weeks following surgery

    Determine if infection is present at surgical site or not.

  2. Frequency of Wound dehiscence

    Time frame: 1-6 weeks following surgery

    Determine if wound reopening (dehiscence) is present at surgical site or not.

  3. Frequency of Seroma

    Time frame: 1-6 weeks following surgery

    Determine if seromas (collection of fluid under the skin) are present at surgical site or not.

Secondary outcomes

  1. Frequency of skin necrosis

    Time frame: 1-6 weeks following surgery

    Measure the frequency of patients who experience skin necrosis in the incision area

  2. Frequency of readmission

    Time frame: 1-6 weeks following surgery

    Measure the frequency of patients who are readmitted following surgery due to wound-related complications

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • 3M

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2022
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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