Surgical Incision
Conditions
Brief summary
The primary aim of this study is to determine if the SSI rate following revision total hip and knee arthroplasty is reduced in patients treated with the PICO device compared to patients with traditional postoperative dressings. Our secondary goals include; comparing the amount of wound drainage, rate of resolution of wound drainage, length of hospital stay, functional outcomes, and economic implications of wound drainage and SSI after revision arthroplasty comparing PICO and traditional dressings.
Interventions
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Subjects who have participated in this trial previously and who were withdrawn 9 .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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical Site Infection | 90-day followup following revision surgery |
Countries
United States
Outcome results
None listed