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)

Study Overview
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Brief Summary
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The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a revision TKA and THA who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. Patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications

Official Title
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A Prospective, Randomized, 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)

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: Aquacel Ag Surgical Dressing
* Device: Single-Use Negative Pressure Wound Therapy (PICO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥18 years old Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty 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 Subjects deemed able to understand and comply with study visit schedule and procedures Exclusion Criteria: Wounds that require daily inspection Active bleeding within the surgical site Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT) Subjects undergoing primary total joint procedures Subjects with a known history of poor compliance with medical treatment 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aquacel Ag Surgical Dressing<br> | Device: Aquacel Ag Surgical Dressing<br> <br> |
| Active Comparator: Single-Use Negative Pressure Wound Therapy (PICO)<br> | Device: Single-Use Negative Pressure Wound Therapy (PICO)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Surgical Site Infection |  | 90 days post-op |