Prevena Spine for Use in Spine Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Incision, Surgical

Intervention / Treatment
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* Device: Prevena Plus 125 Therapy Unit
* Procedure: Spine surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing spine surgery that requires closure by plastic surgeon Over 18 years old Risk Score Cutoff 80+ (Control) Matched to a prospective research participant Exclusion Criteria: Risk Score Cutoff <80 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 Subjects who are pregnant at the date of surgery (SOC for surgery)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1 (control)<br>Retrospective control of patients who did not use Prevena following spine surgery. | Procedure: Spine surgery<br>* Patients will receive spine surgery<br>|
| Active Comparator: Group 2 (Prevena)<br>Prospective group of patients receiving spine surgery who will have Prevena applied to incision area. | Device: Prevena Plus 125 Therapy Unit<br>* 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.<br>Procedure: Spine surgery<br>* Patients will receive spine surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of skin necrosis | Measure the frequency of patients who experience skin necrosis in the incision area | 1-6 weeks following surgery | 
| Frequency of readmission | Measure the frequency of patients who are readmitted following surgery | 1-6 weeks following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure wound therapy, incisional wound therapy, spine surgery