Using Prevena devices to prevent infections in spine surgery
A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery
PHASE4 · Northwestern University · NCT05555355
This study is testing whether using the Prevena device can help prevent infections in patients having spine surgery compared to regular dressings.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05555355 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effectiveness of the Prevena Plus 125 therapy unit in preventing surgical site infections and complications in patients undergoing spine surgery. It compares the outcomes of patients using the Prevena device to those receiving conventional wound dressings. The study aims to identify which patient demographics benefit most from this negative pressure wound therapy approach. By focusing on a single center, the research seeks to provide detailed insights into the efficacy of this intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing spine surgery that requires closure by a plastic surgeon and have a risk score of 80 or higher.
Not a fit: Patients with a risk score below 80 or those with medical conditions that complicate participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections and complications in spine surgery patients.
How similar studies have performed: Previous studies have shown promise with negative pressure wound therapy in various surgical settings, suggesting potential success for this approach in spine surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing spine surgery that requires closure by plastic surgeon 2. Over 18 years old 3. Risk Score Cutoff 80+ 4. (Control) Matched to a prospective research participant Exclusion Criteria: 1. Risk Score Cutoff \<80 2. 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 3. Subjects who are pregnant at the date of surgery (SOC for surgery)
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Robert Galiano, MD
- Email: robert.galiano@nm.org
- Phone: 312-695-6022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgery, Incision, Surgical, negative pressure wound therapy, incisional wound therapy, spine surgery