A Phase 4 interventional study of Prevena Plus 125 Therapy Unit and Spine surgery in Surgery and Incision, Surgical, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Northwestern University · Phase 4, Interventional, and Treatment
A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.
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.
519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.
This study's enrollment of 104 is above the median of 80 across 412 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prospective control of patients who did not use Prevena following spine surgery.
Procedure: Spine surgery
Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.
Device: Prevena Plus 125 Therapy Unit · Procedure: Spine surgery
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.
Patients will receive spine surgery
Frequency of Surgical site infections
Determine if infection is present at surgical site or not.
Time frame: 1-6 weeks following surgery
Frequency of Wound dehiscence
Determine if wound reopening (dehiscence) is present at surgical site or not.
Time frame: 1-6 weeks following surgery
Frequency of Seroma
Determine if seromas (collection of fluid under the skin) are present at surgical site or not.
Time frame: 1-6 weeks following surgery
Frequency of skin necrosis
Measure the frequency of patients who experience skin necrosis in the incision area
Time frame: 1-6 weeks following surgery
Frequency of readmission
Measure the frequency of patients who are readmitted following surgery due to wound-related complications
Time frame: 1-6 weeks following surgery
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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