SurgeryPhase 4NCT05555355
Prevena Spine for Use in Spine Surgery
A Phase 4 study testing Prevena Plus 125 Therapy Unit and Spine surgery in people with Surgery and Incision, Surgical, run by Northwestern University at 1 site in United States.
Trial summary
A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Incision, Surgical
- What is being tested?
- Prevena Plus 125 Therapy Unit and Spine surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing spinal fusion surgery
- Over 18 years old
Who cannot join
- 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
- Subjects who are pregnant at the date of surgery (SOC for surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery
A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.
Read the 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.
- Conditions
- Surgery, Incision, Surgical
- Being tested
- Prevena Plus 125 Therapy Unit, Spine surgery
- Keywords
- negative pressure wound therapy, incisional wound therapy, spine surgery
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena Plus 125 Therapy UnitDevice
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 surgeryProcedure or surgery
Patients will receive spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (control) | Placebo comparator | Prospective control of patients who did not use Prevena following spine surgery. Receives: Procedure: Spine surgery |
| Group 2 (Prevena) | Active comparator | Prospective group of patients receiving spine surgery who will have Prevena applied to incision area. Receives: Device: Prevena Plus 125 Therapy Unit; Procedure: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Surgical site infections
Determine if infection is present at surgical site or not.
Measured: 1-6 weeks following surgery
Frequency of Wound dehiscence
Determine if wound reopening (dehiscence) is present at surgical site or not.
Measured: 1-6 weeks following surgery
Frequency of Seroma
Determine if seromas (collection of fluid under the skin) are present at surgical site or not.
Measured: 1-6 weeks following surgery
Secondary outcomes (2)
Frequency of skin necrosis
Measure the frequency of patients who experience skin necrosis in the incision area
Measured: 1-6 weeks following surgery
Frequency of readmission
Measure the frequency of patients who are readmitted following surgery due to wound-related complications
Measured: 1-6 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Dec 2022
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single center study
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555355
- Sponsor's protocol ID
- STU00216293
- Status last verified
- Dec 2025
- First submitted
- 4 May 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center Study for the Investigation of the Use of Prevena Vacuum-Assisted Closure Devices in Patients Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT05555355
- Acronym / sponsor ID
- STU00216293
- Conditions
- Surgery, Incision, Surgical
- Keywords
- negative pressure wound therapy, incisional wound therapy, spine surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center study
| Arm | Type | Receives |
|---|---|---|
| Group 1 (control) | Placebo comparator | Procedure: Spine surgeryProspective control of patients who did not use Prevena following spine surgery. |
| Group 2 (Prevena) | Active comparator | Device: Prevena Plus 125 Therapy Unit, Procedure: Spine surgeryProspective group of patients receiving spine surgery who will have Prevena applied to incision area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing spinal fusion surgery
- Over 18 years old
Key exclusion criteria (2 listed)
- 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
- Subjects who are pregnant at the date of surgery (SOC for surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevena Plus 125 Therapy UnitThe 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. | Device | Group 2 (Prevena) |
| Spine surgeryPatients will receive spine surgery | Procedure or surgery | Group 1 (control), Group 2 (Prevena) |
Primary outcome
Frequency of Surgical site infections
Time frame: 1-6 weeks following surgery
Determine if infection is present at surgical site or not.
Frequency of Wound dehiscence
Time frame: 1-6 weeks following surgery
Determine if wound reopening (dehiscence) is present at surgical site or not.
Frequency of Seroma
Time frame: 1-6 weeks following surgery
Determine if seromas (collection of fluid under the skin) are present at surgical site or not.
2 secondary outcomes
Frequency of skin necrosis
Time frame: 1-6 weeks following surgery
Frequency of readmission
Time frame: 1-6 weeks following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevena Plus 125 Therapy Unit and Spine surgery in people with Surgery and Incision, Surgical, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Surgical site infections (time frame: 1-6 weeks following surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.