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Clinical Evaluation of the SNaP Wound Care System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01113658
Recruitment Status : Withdrawn (The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.)
First Posted : April 30, 2010
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute and Chronic Wounds Pressure Ulcers Trauma Wounds Diabetic Foot Ulcers Venous Stasis Ulcers Device: SNaP Wound Care System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
Estimated Study Start Date : March 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Frequency of complaints about device use and operation [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113658


Locations
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United States, California
San Francisco Center for Advanced Wound Care
Daly City, California, United States, 94015
The SF Center For Advanced Wound Care At
Daly City, California, United States, 94015
Sponsors and Collaborators
KCI USA, Inc.
Investigators
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Principal Investigator: Kristine K Nemes, DPM Seton Hospital
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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01113658    
Other Study ID Numbers: SNaP-113009
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Keywords provided by KCI USA, Inc.:
negative pressure wound therapy
NPWT
Spiracur
SNaP Wound Care System
Additional relevant MeSH terms:
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Diabetic Foot
Varicose Ulcer
Foot Ulcer
Pressure Ulcer
Ulcer
Wounds and Injuries
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Varicose Veins