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

Study Overview
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Brief Summary
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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.

Official Title
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Post-market, Randomized, Open-Label, Multicenter, Study to Evaluate the Effectiveness of Closed Incision Negative Pressure Therapy Versus Standard of Care Dressings in Reducing Surgical Site Complications in Subjects With Revision of a Failed Total Knee Arthroplasty (PROMISES)

Conditions
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Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease, Musculoskeletal Disease, Prosthesis-Related Infections, Infection, Postoperative Complications, Pathologic Processes

Intervention / Treatment
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* Device: Closed Incision Negative Pressure Therapy (ciNPT)
* Device: Standard of Care Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Closed Incision Negative Pressure Therapy (ciNPT)<br>Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit | Device: Closed Incision Negative Pressure Therapy (ciNPT)<br>* 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.<br>* Other names: Prevena Plus 125 Therapy Unit;|
| Active Comparator: Standard of Care Dressing<br>Silver impregnated dressing | Device: Standard of Care Dressing<br>* A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.<br>* Other names: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 90 days after TKA revision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) | 90 day subject incidence of any SSI (superficial or deep) | 90 days after TKA revision | 
| Number of Participants With Deep Surgical Site Infection | 90 day subject incidence of deep surgical site infection | 90 days after TKA revision |