Clinical Evaluation of the SNaP Wound Care System

July 29, 2022 updated by: 3M

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Daly City, California, United States, 94015
        • San Francisco Center for Advanced Wound Care
      • Daly City, California, United States, 94015
        • The SF Center For Advanced Wound Care At

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
Device: SNaP Wound Care System

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.

Other Names:
  • Spiracur SNaP Wound Care System
  • SNaP
  • The SNaP System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of complaints about device use and operation
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3M

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2010

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

April 30, 2010

Study Record Updates

Last Update Posted (Actual)

August 1, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNaP-113009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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