NPWTi on Closure of Chronic Pressure Sores

Study Overview
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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.

Official Title
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Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial

Conditions
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Pressure Sore

Intervention / Treatment
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* Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System
* Other: Standard of Care (Wet-to-dry dressings)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (Wet-to-dry dressings)<br>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)<br>* Wet-to-dry dressings<br>|
| Experimental: Treatment (NPWT with Instillation)<br>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<br>* 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.<br>|

What is the study measuring?
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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 |