Clinical Evaluation of the SNaP Wound Care System

NCT ID: NCT01113658

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-08-31

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SNaP

SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

Group Type EXPERIMENTAL

SNaP Wound Care System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Spiracur SNaP Wound Care System SNaP The SNaP System

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristine K Nemes, DPM

Role: PRINCIPAL_INVESTIGATOR

Seton Hospital

Locations

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San Francisco Center for Advanced Wound Care

Daly City, California, United States

Site Status

The SF Center For Advanced Wound Care At

Daly City, California, United States

Site Status

Countries

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United States

Other Identifiers

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SNaP-113009

Identifier Type: -

Identifier Source: org_study_id

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