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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (control) | Placebo Comparator | Prospective control of patients who did not use Prevena following spine surgery. |
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| Group 2 (Prevena) | Active Comparator | Prospective group of patients receiving spine surgery who will have Prevena applied to incision area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Plus 125 Therapy Unit | Device | 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. |
| 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 |
| 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 due to wound-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Single center study
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| Spine surgery | Procedure | Patients will receive spine surgery |
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| 1-6 weeks following surgery |