Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

Pre-operative Inclusion Criteria:

The subject:

• is at least 22 years of age on the date of informed consent
• is able to provide their own informed consent
• requires a TKA revision defined as one of the following:
• a one-stage aseptic revision procedure
• a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
• removal of cement spacer and re-implantation procedure
• open reduction and internal fixation of peri-prosthetic fractures
• has one or more of the following:
• a body mass index (BMI) greater than 35 kg/m2
• a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
• history of or current peripheral vascular disease
• the presence of lymphedema in the operative limb
• insulin-dependent diabetes mellitus
• current tobacco use or previous history of smoking and quitting within the past 30 days
• a history of prior infection of the operative site
• current use of immunomodulators or steroids
• current or history of cancer or hematological malignancy (excluding localized skin cancer)
• rheumatoid arthritis
• current renal failure or dialysis
• malnutrition as determined by the investigator
• liver disease as determined by the investigator
• status post solid organ transplant
• HIV
• is willing and able to return for all scheduled study visits
• if female, has a negative urine or serum pregnancy test at screening and day of revision surgery. Women who have had surgical sterilization by a medically accepted method such as tubal ligation, hysterectomy, or oophorectomy or are post-menopausal, defined as not having menstruation for >= 12 months will be excluded from requiring this test.

Intra-operative Inclusion Criteria:

The subject:

• continues to meet all pre-operative inclusion criteria
• has undergone a TKA revision resulting in a closed surgical incision

Pre-operative Exclusion Criteria:

The subject:

• is pregnant or lactating
• will undergo a bilateral TKA within the same operative visit
• will undergo a bilateral TKA in which the first TKA surgery is on the knee selected for study
• will undergo a staged bilateral TKA in which the TKA revision surgery for the knee under study occurs within 30 days of the first TKA procedure
• was previously randomized in this protocol
• has a systemic active infection at the time of revision not including chronic viral infections such as HIV or hepatitis
• has a remote-site skin infection at the time of revision
• was tattooed on the area of the incision within 30 days prior to randomization
• has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin)
• has known sensitivity to silver
• is currently enrolled in another investigational trial that requires additional interventions
• is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
• has localized skin cancer around the incision site

Intra-operative Exclusion Criteria:

The subject:

• is found to meet any of the pre-operative exclusion criteria
• has a surgical incision that precludes placement of dressing
• has a TKA revision resulting in a muscle flap
• has a TKA revision resulting in the placement of a spacer
• has an incision drainage and debridement procedure only
• has a surgical incision closed with skin glue