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RECRUITING
NCT05598398
PHASE4

NPWTi on Closure of Chronic Pressure Sores

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

Official title: Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2022-09-26

Completion Date

2027-05

Last Updated

2026-03-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

V.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.

OTHER

Standard of Care (Wet-to-dry dressings)

Wet-to-dry dressings

Locations (1)

Northwestern University

Chicago, Illinois, United States