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NPWTi on Closure of Chronic Pressure Sores

RecruitingPhase 4Ages 18 Years - anyAllNorthwestern University
NCT05598398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • V.A.C.Ulta™ Negative Pressure Wound Therapy System
  • Standard of Care (Wet-to-dry dressings)
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Where

1 site
Northwestern University
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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