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NCT Number: NCT05598398

NPWTi on Closure of Chronic Pressure Sores

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.

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Key information

Conditions

Pressure Sore Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Standard of Care (Wet-to-dry dressings)

Other

Wet-to-dry dressings

Primary outcomes

  1. Total Length of Stay

    Time frame: up to 3 months

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

Secondary outcomes

  1. Cost Analysis

    Time frame: Through study completion, approximately 5 months

    Total costs of dressings, hospital stay, direct patient care and other costs involved in inpatient care.

  2. Number of debridements

    Time frame: Through study completion, approximately 5 months

    Record the total number of debridements performed at the wound site throughout the duration of the study

  3. Successful closure of pressure sores

    Time frame: 2 weeks and 6 weeks post-closure surgery

    Patients will be assessed for proper closure of the wound

Other outcomes

  1. Proteomic analysis

    Time frame: 1 year post-closure surgery

    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.

  2. Bioburden assessment

    Time frame: Through study completion, approximately 5 months

    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.

  3. Wound characteristic assessments

    Time frame: 1 year post-closure surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Huffman, B.S.

CONTACT

[email protected]

3129267037

Robert Galiano, MD

CONTACT

[email protected]

3129267037

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • 3M

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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