A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)
NCT ID: NCT02664168
Last Updated: 2018-04-12
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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UNKNOWN
NA
INTERVENTIONAL
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
Study Groups
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Aquacel Ag Surgical Dressing
Aquacel Ag Surgical Dressing
Single-Use Negative Pressure Wound Therapy (PICO)
Single-Use Negative Pressure Wound Therapy (PICO)
Interventions
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Aquacel Ag Surgical Dressing
Single-Use Negative Pressure Wound Therapy (PICO)
Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
5. Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion Criteria
2. Active bleeding within the surgical site
3. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
5. Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
6. Subjects undergoing primary total joint procedures
7. Subjects with a known history of poor compliance with medical treatment
8. Subjects who have participated in this trial previously and who were withdrawn 9 . Subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
18 Years
ALL
No
Sponsors
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Rothman Institute Orthopaedics
OTHER
Responsible Party
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Locations
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Rothman Institute
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016Jpar01
Identifier Type: -
Identifier Source: org_study_id
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