Pressure SorePhase 4NCT05598398
NPWTi on Closure of Chronic Pressure Sores
A Phase 4 study testing V.A.C.Ulta™ Negative Pressure Wound Therapy System in people with Pressure Sore, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Sore
- What is being tested?
- V.A.C.Ulta™ Negative Pressure Wound Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischial and sacral wounds at stage 3 and 4.
- Any pressure sore that has the potential for a good seal.
Who cannot join
- Any pressure sore that does not have potential for a good seal.
- Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
- Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
- Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Robert Galiano, MD, 3129267037, robert.galiano@nm.org
Kristin Huffman, 3129267037, kristin.huffman@northwestern.edu
About this study
Official title: Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial
The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.
- Conditions
- Pressure Sore
- Being tested
- V.A.C.Ulta™ Negative Pressure Wound Therapy System, Standard of Care (Wet-to-dry dressings)
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V.A.C.Ulta™ Negative Pressure Wound Therapy SystemDevice
The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) - cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Standard of Care (Wet-to-dry dressings)Other
Wet-to-dry dressings
| Study group | Role | What they receive |
|---|---|---|
| Control (Wet-to-dry dressings) | Active comparator | Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore. Receives: Other: Standard of Care (Wet-to-dry dressings) |
| Treatment (NPWT with Instillation) | Experimental | Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore. Receives: Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Length of Stay
Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery
Measured: up to 3 months
Secondary outcomes (3)
Cost Analysis
Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.
Measured: Through study completion, approximately 5 months
Number of debridements
Record the total number of debridements performed at the wound site throughout the duration of the study
Measured: Through study completion, approximately 5 months
Successful closure of pressure sores
Patients will be assessed for proper closure of the wound
Measured: 2 weeks and 6 weeks post-closure surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start26 Sep 2022
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure SoreStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Robert Galiano, Northwestern University
- Investigators
- Robert Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598398
- Sponsor's protocol ID
- STU00216075
- Status last verified
- Feb 2026
- First submitted
- 20 Oct 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05598398
- Acronym / sponsor ID
- STU00216075
- Conditions
- Pressure Sore
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Oct 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.
The primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Wet-to-dry dressings) | Active comparator | Other: Standard of Care (Wet-to-dry dressings)Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore. |
| Treatment (NPWT with Instillation) | Experimental | Device: V.A.C.Ulta™ Negative Pressure Wound Therapy SystemSubjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ischial and sacral wounds at stage 3 and 4.
- Any pressure sore that has the potential for a good seal.
Key exclusion criteria (4 listed)
- Any pressure sore that does not have potential for a good seal.
- Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
- Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
- Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.
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 |
|---|---|---|
| V.A.C.Ulta™ Negative Pressure Wound Therapy SystemThe V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) - cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. | Device | Treatment (NPWT with Instillation) |
| Standard of Care (Wet-to-dry dressings)Wet-to-dry dressings | Other | Control (Wet-to-dry dressings) |
Primary outcome
Total Length of Stay
Time frame: up to 3 months
Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery
3 secondary outcomes
Cost Analysis
Time frame: Through study completion, approximately 5 months
Number of debridements
Time frame: Through study completion, approximately 5 months
Successful closure of pressure sores
Time frame: 2 weeks and 6 weeks post-closure surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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.
Robert Galiano, MD principal investigator
Northwestern University
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 V.A.C.Ulta™ Negative Pressure Wound Therapy System in people with Pressure Sore, 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 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Galiano, MD (3129267037, robert.galiano@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Length of Stay (time frame: up to 3 months). 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 25 Mar 2026.