RecruitingPhase 4NCT05598398

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


Sponsor

Northwestern University

Enrollment

62 participants

Start Date

Sep 26, 2022

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of Care (Wet-to-dry dressings) and a medical device called V.A.C.Ulta™ Negative Pressure Wound Therapy System for people with pressure sore. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEV.A.C.Ulta™ Negative Pressure Wound Therapy System

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.

OTHERStandard of Care (Wet-to-dry dressings)

Wet-to-dry dressings


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT05598398


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