NPWTi on Closure of Chronic Pressure Sores

NCT05598398 | Recruiting Phase 4 FDA Device

• 1 other identifier: STU00216075
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total Length of Stay

  Record the number of days spent in the hospital from initial debridement (first visit with plastic surgeon) to discharge from hospital following surgery

  up to 3 months

Secondary Outcomes (3)

• Cost Analysis

  Through study completion, approximately 5 months

• Number of debridements

  Through study completion, approximately 5 months

• Successful closure of pressure sores

  2 weeks and 6 weeks post-closure surgery

Other Outcomes (3)

• Proteomic analysis

  1 year post-closure surgery

• Bioburden assessment

  Through study completion, approximately 5 months

• Wound characteristic assessments

  1 year post-closure surgery

Study Arms (2)

Control (Wet-to-dry dressings)

ACTIVE COMPARATOR

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

Other: Standard of Care (Wet-to-dry dressings)

Treatment (NPWT with Instillation)

EXPERIMENTAL

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.

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

Interventions

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

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.

Treatment (NPWT with Instillation)

Standard of Care (Wet-to-dry dressings) OTHER

Wet-to-dry dressings

Control (Wet-to-dry dressings)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischial and sacral wounds at stage 3 and 4.
• Any pressure sore that has the potential for a good seal.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 3M: collaborator
• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert Galiano, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Galiano, MD

CONTACT

3129267037; robert.galiano@nm.org

Kristin Huffman, B.S.

CONTACT

3129267037; kristin.huffman@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 28, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-02

Locations

US (1)