Clinical Evaluation of the SNaP Wound Care System

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

SNaP Wound Care SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

San Francisco Center for Advanced Wound Care

Daly City, California, United States

The SF Center For Advanced Wound Care At

Daly City, California, United States

Outcomes

Primary Outcomes

Frequency of complaints about device use and operation

Time frame: 16 weeks

Data from ClinicalTrials.gov

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