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Recruiting NCT05598398

NPWTi on Closure of Chronic Pressure Sores

Phase IV Interventional Pressure Sore

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: V.A.C.Ulta™ Negative Pressure Wound Therapy System, Standard of Care (Wet-to-dry dressings).
Who it may be relevant to
Registry conditions: Pressure Sore. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Total Length of Stay [Time frame: up to 3 months]
Secondary outcome measures (3)
  • Cost Analysis [Time frame: Through study completion, approximately 5 months]
  • Number of debridements [Time frame: Through study completion, approximately 5 months]
  • Successful closure of pressure sores [Time frame: 2 weeks and 6 weeks post-closure surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT05598398 · STU00216075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗