Prevena Spine for Use in Spine Surgery

Phase 4

Recruiting

• Conditions: Surgery; Incision, Surgical
• Interventions: Procedure: Spine surgery; Device: Prevena Plus 125 Therapy Unit

• Registration Number: NCT05555355
• Lead Sponsor: Northwestern University

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.

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 Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-26
• Study Start: 2022-12-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 285

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (control)	Spine surgery	Retrospective control of patients who did not use Prevena following spine surgery.
Group 2 (Prevena)	Prevena Plus 125 Therapy Unit	Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.
Group 2 (Prevena)	Spine surgery	Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States