NPWTi on Closure of Chronic Pressure Sores

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2025-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Pressure Sore

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standard of Care (Wet-to-dry dressings)

Intervention Type OTHER

Wet-to-dry dressings

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Standard of Care (Wet-to-dry dressings)

Wet-to-dry dressings

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No