Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2022-12-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 (control)
Prospective control of patients who did not use Prevena following spine surgery.
Spine surgery
Patients will receive spine surgery
Group 2 (Prevena)
Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.
Prevena Plus 125 Therapy Unit
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
Patients will receive spine surgery
Interventions
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Prevena Plus 125 Therapy Unit
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
Patients will receive spine surgery
Eligibility Criteria
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Inclusion Criteria
2. Over 18 years old
Exclusion Criteria
2. Subjects who are pregnant at the date of surgery (SOC for surgery)
18 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Robert Galiano
Associate Professor of Surgery
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00216293
Identifier Type: -
Identifier Source: org_study_id
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