Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (The study was terminated by Spiracur (original sponsor).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.

Tracking Information
First Submitted Date  ICMJE April 28, 2010
First Posted Date  ICMJE April 30, 2010
Last Update Posted Date September 7, 2020
Estimated Study Start Date  ICMJE March 2010
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2010)
Frequency of complaints about device use and operation [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
  • Frequency of complaints about device use and operation [ Time Frame: 16 weeks ]
  • Adverse effects [ Time Frame: 16 weeks ]
  • Incidence of severe maceration of healthy skin and periwound [ Time Frame: 16 weeks ]
  • Issues with the device performance - including leaks [ Time Frame: 16 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
  • Percent of wounds closed by 16 weeks [ Time Frame: 16 weeks ]
  • Time to complete wound bed granulation [ Time Frame: 16 weeks ]
  • Compliance with therapy [ Time Frame: 16 weeks ]
  • Quality of life [ Time Frame: 16 weeks ]
  • Percent of healing [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the SNaP Wound Care System
Official Title  ICMJE Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute and Chronic Wounds
  • Pressure Ulcers
  • Trauma Wounds
  • Diabetic Foot Ulcers
  • Venous Stasis Ulcers
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: SNaP
SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
Intervention: Device: SNaP Wound Care System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2010)
60
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01113658
Other Study ID Numbers  ICMJE SNaP-113009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KCI USA, Inc.
Study Sponsor  ICMJE KCI USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristine K Nemes, DPM Seton Hospital
PRS Account KCI USA, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP