This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
294
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Cleveland Clinic
Weston, Florida, United States
Emory University Orthopedics & Spine Hospital
Tucker, Georgia, United States
LSU Health Science Center
New Orleans, Louisiana, United States
University of Missouri Health Care
Columbia, Missouri, United States
Northwell Health - SouthSide Hospital
Bay Shore, New York, United States
New York University (NYU)
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Northwell Health - Lenox Hill Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
...and 7 more locations
Number of Participants With Surgical Site Complications (SSC)
The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following: * Superficial Surgical Site Infection (SSI) * Deep SSI * Full thickness skin dehiscence * Seroma or hematoma requiring drainage or surgery * Skin necrosis * Continued drainage at the time of dressing removal
Time frame: within 90 days after TKA revision
Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
90 day subject incidence of any SSI (superficial or deep)
Time frame: 90 days after TKA revision
Number of Participants With Deep Surgical Site Infection
90 day subject incidence of deep surgical site infection
Time frame: 90 days after TKA revision
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