Using Negative Pressure Wound Therapy to Heal Chronic Pressure Sores
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
Run by Northwestern University · NCT05598398 · Data updated 2026-11-12
This study tests if a special wound therapy can help heal serious pressure sores better than regular dressings for patients with deep wounds.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | September 26, 2022 |
| Main results expected | January 2027 |
| Study ends | May 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT05598398 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with stage 3 and 4 ischial or sacral pressure sores that can achieve a good seal.
✕Probably not a fit
Patients with pressure sores that do not have the potential for a good seal or those with fecal incontinence may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of the Negative Pressure Wound Therapy with instillation (NPWTi) system in closing chronic pressure sores compared to standard wet-to-dry dressings. It focuses on patients with stage 3 and 4 ischial and sacral wounds that have the potential for a good seal. The study aims to demonstrate that NPWTi can achieve better healing outcomes following debridement than traditional methods. This is a post-market, on-label study conducted at Northwestern University.
Why it matters
Potential benefit: If successful, this approach could significantly improve healing rates for patients with chronic pressure sores.
How similar studies have gone: Other studies have shown positive outcomes with similar negative pressure wound therapy approaches, indicating potential for success in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ischial and sacral wounds at stage 3 and 4. 2. Any pressure sore that has the potential for a good seal. Exclusion Criteria: 1. Any pressure sore that does not have potential for a good seal. 2. Patients with fecal incontinence (due to potential for pressure sore to be near the anus). 3. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.). 4. 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.
Where it's running
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Northwestern University
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Robert Galiano, MD — Northwestern University
- Study coordinator: Robert Galiano, MD
- Email: robert.galiano@nm.org
- Phone: 3129267037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.