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 unconfirmed · Not applicable
Conditions studied: Surgical Wound Infection
In brief
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
Key facts
- Study ID
- NCT02664168
- Run by
- Rothman Institute Orthopaedics
- Starts
- 2016-01-01
- Last updated by the study team
- 2018-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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- Subjects who have participated in this trial previously and who were withdrawn 9 .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)
Where it is running
- Rothman Institute — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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