Combination of Taliderm® and Vacuum-assisted Closure (VAC) for Treatment of Pressure Ulcers
NCT ID: NCT02237287
Last Updated: 2015-09-29
Study Results
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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TERMINATED
EARLY_PHASE1
24 participants
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine nanofibers (sNAG) was studied in a prospective randomized clinical trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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wound dressing with VAC
After wound debridement wounds are treated for 2 weeks with VAC dressing alone
wound dressing with VAC
wound dressing with VAC and sNAG under Antiaggregation
In patients being under antiaggregation with Aspirin® 100mg daily, after wound debridement wounds are treated with VAC and sNAG
wound dressing with VAC and sNAG without antiaggregation
wound dressing with VAC
wound dressing with VAC and sNAG under Antiaggregation
wound dressing with VAC and sNAG without antiaggregation
In patients NOT being under antiaggregation, after wound debridement wounds are treated with VAC and sNAG
wound dressing with VAC and sNAG without antiaggregation
wound dressing with VAC
Interventions
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wound dressing with VAC and sNAG without antiaggregation
wound dressing with VAC
wound dressing with VAC and sNAG under Antiaggregation
Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 18 years of age
* Ability to obtain informed consent
Exclusion Criteria
* Immunosuppression, Hemodialysis, Steroids
* Pregnancy
* Sepsis
18 Years
ALL
No
Sponsors
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Marine Polymer Technologies, Inc.
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Dirk J. Schaefer, Prof.Dr.
Role: STUDY_DIRECTOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Swiss Paraplegic Centre Nottwil
Nottwil, , Switzerland
Countries
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Other Identifiers
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2010-MD-0007
Identifier Type: -
Identifier Source: org_study_id
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