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

This study is currently Recruiting

October 2010 By Spiracur, Inc.

First Recieved on April 28, 2010

Last Updated on October 22, 2010

Sponsor: Spiracur, Inc.
Collaborators:
Information provided by: Spiracur, Inc.
Identifier: NCT01113658

Purpose

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
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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

Investigators

  • Investigator: Kristine K Nemes, DPM - Principal Investigator - Seton Hospital

Locations

  • The SF Center For Advanced Wound Care At

    Daly City, California 94015 United States

  • San Francisco Center for Advanced Wound Care

    Daly City, California 94015 United States

Conditions related to this trial:

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