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Feasibility Study of a Novel Device for Chronic Wounds

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: NCT00660049
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : January 20, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Anne Chang, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

Condition or disease Intervention/treatment Phase
Ulcer Wounds and Injuries Device: SNaP Advanced Wound Care System Other: SNaP Not Applicable

Detailed Description:
This is an open label study
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of a Novel Device for Chronic Wounds
Study Start Date : March 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SNaP application
This is an "open label" pilot study of SNaP Advanced Wound Care System
 Device: SNaP Advanced Wound Care System
Application of negative pressure device daily per instructions
Other Name: SNaP device (SmartNegative Pressure device)

Other: SNaP
Daily use
Other Name: SNaP device

Other: SNaP
Daily application per protocol


Outcome Measures
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Primary Outcome Measures :
  1. Ease of Use for Patients [ Time Frame: Baseline up to 31 days ]
    Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.


Eligibility Criteria
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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:- Venous stasis ulcer or other chronic wound on the lower extremity that is >1.5cm and <10cm at widest point

  • The wound must have at least 2 cm of intact epithelium surrounding it.
  • A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved.
  • Ulcer must not have healed for >14 days under standard treatment.
  • Chronic wound with prior graft placement will be allowed in the study.
  • Patient is >18 years old.
  • Willing and able to sign informed consent.

Exclusion Criteria:- Active wound infection.

  • 3+ or greater pitting edema of lower extremity
  • History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study.
  • Thick eschar at wound base after debridement.
  • Wound location is not amenable to forming an airtight seal and placement of device.
  • Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome.
  • Current smoker (must have quit for >3 weeks)
  • Wound with exposed bone, blood vessels, tendon
  • Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone
  • Fasting blood sugar >200 by study personnel administered bedside fingerstick blood glucose
  • Ankle brachial index less than lower limit of normal (<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds).
  • Pregnancy
  • Incapable of giving informed consent
  • Inability to comply with study procedures including lack of telephone access for week 8 telephone survey
Contacts and Locations
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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): NCT00660049


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
KCI USA, Inc.
Investigators
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Principal Investigator: Dr. Anne Lynn S. Chang Stanford University
More Information
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Publications:

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Responsible Party: Anne Chang, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00660049    
Other Study ID Numbers: SU-02252008-1026
IRB Protocol #: 11074 ( Other Identifier: Stanford University )
First Posted: April 17, 2008    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing
Additional relevant MeSH terms:
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Wounds and Injuries