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

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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Sore
• Intervention / Treatment: Other: Standard of Care (Wet-to-dry dressings); Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robert Galiano, MD; Phone Number: 3129267037; Email: robert.galiano@nm.org
• Study Contact Backup: Name: Kristin Huffman, B.S.; Phone Number: 3129267037; Email: kristin.huffman@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Robert Galiano, MD; Phone Number: 3129267037; Email: robert.galiano@nm.org
      • Contact: Kristin Huffman; Phone Number: 3129267037; Email: kristin.huffman@northwestern.edu
      • Principal Investigator: Robert Galiano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Standard of Care (Wet-to-dry dressings); Wet-to-dry dressings
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Analysis	Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.	Through study completion, approximately 5 months
Number of debridements	Record the total number of debridements performed at the wound site throughout the duration of the study	Through study completion, approximately 5 months
Successful closure of pressure sores	Patients will be assessed for proper closure of the wound	2 weeks and 6 weeks post-closure surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomic analysis	Amount of bacteria present in frozen tissue that was collected at treatment day 1 will be determined and compared between groups using a two sample t-test.	1 year post-closure surgery
Bioburden assessment	Photos of the wound will be taken with a specialized bioburden camera, which can pick up on bacterial load of the wound. Photos will be taken before debridement, after debridement, after every dressing change, and on the day of surgery.	Through study completion, approximately 5 months
Wound characteristic assessments	Wound characteristics collected by the 3D imaging as well as bioburden collected by the bioburden camera will be compared between the control and study groups. Each respective comparison will involve 2 independent sample t-tests.	1 year post-closure surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: 3M
• Investigators: Principal Investigator: Robert Galiano, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: STU00216075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes