Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2008-03-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SNaP application
This is an "open label" pilot study of SNaP Advanced Wound Care System
SNaP Advanced Wound Care System
Application of negative pressure device daily per instructions
SNaP
Daily use
SNaP
Daily application per protocol
Interventions
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SNaP Advanced Wound Care System
Application of negative pressure device daily per instructions
SNaP
Daily use
SNaP
Daily application per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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3M
INDUSTRY
Stanford University
OTHER
Responsible Party
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Anne Chang
Professor
Principal Investigators
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Dr. Anne Lynn S. Chang
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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Fong KD, Hu D, Eichstadt SL, Gorell E, Munoz CA, Lorenz HP, Chang AL. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010 Sep;22(9):230-6.
Other Identifiers
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IRB Protocol #: 11074
Identifier Type: OTHER
Identifier Source: secondary_id
SU-02252008-1026
Identifier Type: -
Identifier Source: org_study_id