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)



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 2016
Contact:Tiffany Morrison, MS
Email:tiffany.morrison@rothmaninstitute.com
Phone:267-339-7818

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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)

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


Inclusion Criteria:

1. Patient ≥18 years old

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:

1. Wounds that require daily inspection

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)
We found this trial at
1
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Philadelphia, Pennsylvania 19107
Phone: 267-339-7818
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Philadelphia, PA
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