Actively Recruiting
NPWTi on Closure of Chronic Pressure Sores
Led by Northwestern University · Updated on 2026-03-25
62
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
3
3M
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
NPWTi on Closure of Chronic Pressure Sores
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ischial and sacral wounds at stage 3 and 4.
- Any pressure sore that has the potential for a good seal.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
R
Robert Galiano, MD
CONTACT
K
Kristin Huffman, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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