NPWTi on Closure of Chronic Pressure Sores
Recruiting
Phase 4
Interventional Study
Pressure Sore
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 62 (estimated)
- Sponsor
- Northwestern University · Other
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About This 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 debr…
Trial Locations
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Eligibility 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…
Contacts