NPWTi on Closure of Chronic Pressure Sores
Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial
Northwestern University
62 participants
Sep 26, 2022
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria2
- Ischial and sacral wounds at stage 3 and 4.
- Any pressure sore that has the potential for a good seal.
Exclusion Criteria4
- 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.
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Interventions
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.
Wet-to-dry dressings
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05598398