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Prevena Spine for Use in Spine Surgery

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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)

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

Trial contacts and locations

1

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Central trial contact

Robert Galiano, MD; Tokoya Williams, MD

Data sourced from clinicaltrials.gov

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