Recruiting

NPWTi vs. Wet-to-Dry

Sponsor:

Northwestern University

Code:

NCT05598398

Conditions

Pressure Sore

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Standard of Care (Wet-to-dry dressings)

Study Details

Brief 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.

Conditions

Pressure Sore

Study ID

NCT05598398

Start date

Sep 26, 2022

Status verified date

Feb, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control (Wet-to-dry dressings)

Subjects randomized to the control group with receive standard of care (wet-to-dry dressings) for treatment of their pressure sore.

experimental: Treatment (NPWT with Instillation)

Subjects who are randomized into the treatment arm (NPWT with Instillation) will receive the V.A.C. VeraFlo™ Cleanse Choice Dressing Systems for treatment of their pressure sore.

Interventions

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.

Standard of Care (Wet-to-dry dressings)

Wet-to-dry dressings

Primary outcome measure

  • Total Length of Stay [ Time Frame: up to 3 months ]

Central Contacts and Locations

Central contacts

Robert Galiano, MD

3129267037robert.galiano@nm.org

Kristin Huffman, B.S.

3129267037kristin.huffman@northwestern.edu

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Robert Galiano, MD

3129267037robert.galiano@nm.org

Kristin Huffman

3129267037kristin.huffman@northwestern.edu

Principal Investigator:

Robert Galiano, MD

More Information

Sponsor

Northwestern University

Last update posted

Mar 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-03-25.