Prevena Spine for Use in Spine Surgery

Northwestern University

Status and phase: Enrolling; Phase 4

Conditions: Surgery; Incision, Surgical

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05555355

STU00216293

Details and patient eligibility

About

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

Full 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.

Enrollment: 285 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 2 patient groups, including a placebo group

Group 1 (control)

Placebo Comparator group

Description:

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

Treatment:

Procedure: Spine surgery

Group 2 (Prevena)

Active Comparator group

Description:

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

Treatment:

Device: Prevena Plus 125 Therapy Unit

Procedure: Spine surgery