Incision, Surgical, Surgery
Conditions
Keywords
negative pressure wound therapy, incisional wound therapy, spine surgery
Brief summary
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
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.
Interventions
DEVICEPrevena 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.
PROCEDURESpine surgery
Patients will receive spine surgery
Sponsors
3M
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single center study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients undergoing spinal fusion surgery 2. Over 18 years old
Exclusion criteria
1. 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 judgment of the Investigator, would make the subject inappropriate for entry into this study 2. Subjects who are pregnant at the date of surgery (SOC for surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Surgical site infections | 1-6 weeks following surgery | Determine if infection is present at surgical site or not. |
| Frequency of Wound dehiscence | 1-6 weeks following surgery | Determine if wound reopening (dehiscence) is present at surgical site or not. |
| Frequency of Seroma | 1-6 weeks following surgery | Determine if seromas (collection of fluid under the skin) are present at surgical site or not. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of skin necrosis | 1-6 weeks following surgery | Measure the frequency of patients who experience skin necrosis in the incision area |
| Frequency of readmission | 1-6 weeks following surgery | Measure the frequency of patients who are readmitted following surgery due to wound-related complications |
Countries
United States
Outcome results
None listed