Clinical Evaluation of the SNaP Wound Care System

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.

Official Title
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Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System

Conditions
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Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers, Venous Stasis Ulcers

Intervention / Treatment
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* Device: SNaP Wound Care System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Wound < 10 cm in greatest diameter Patient >18 years of age Willing and able to sign informed consent Exclusion Criteria: Patients with wound-related cellulitis Patients with thick eschar at wound base post debridement Patients with wounds located in an area not amenable to forming an air- tight seal Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome Patient has untreated osteomyelitis Patient is allergic to wound care products Patient wounds with exposed blood vessels not suitable for negative pressure therapy Pregnant or pregnancy-suspected patients Subject actively participating in other clinical trials that conflict with the current 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNaP<br>SNaP disposable, mechanically powered Negative Pressure Wound Therapy System | Device: SNaP Wound Care System<br>* The intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts. The Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician.<br>* Other names: The SNaP System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of complaints about device use and operation |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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negative pressure wound therapy, NPWT, Spiracur, SNaP Wound Care System