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

3M Company

Status: Completed

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

Treatments: Device: Standard of Care Dressing; Device: Closed Incision Negative Pressure Therapy (ciNPT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03274466

KCI.PREVENA.2017.01

Details and patient eligibility

About

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.

Enrollment: 294 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

  1. a one-stage aseptic revision procedure
  2. a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
  3. removal of cement spacer and re-implantation procedure
  4. open reduction and internal fixation of peri-prosthetic fractures

• has one or more of the following:

  1. a body mass index (BMI) greater than 35 kg/m2
  2. a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
  3. history of or current peripheral vascular disease
  4. the presence of lymphedema in the operative limb
  5. insulin-dependent diabetes mellitus
  6. current tobacco use or previous history of smoking and quitting within the past 30 days
  7. a history of prior infection of the operative site
  8. current use of immunomodulators or steroids
  9. current or history of cancer or hematological malignancy (excluding localized skin cancer)
  10. rheumatoid arthritis
  11. current renal failure or dialysis
  12. malnutrition as determined by the investigator
  13. liver disease as determined by the investigator
  14. status post solid organ transplant
  15. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

294 participants in 2 patient groups

Closed Incision Negative Pressure Therapy (ciNPT)

Experimental group

Description:

Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit

Treatment:

Device: Closed Incision Negative Pressure Therapy (ciNPT)

Standard of Care Dressing

Active Comparator group

Description:

Silver impregnated dressing

Treatment:

Device: Standard of Care Dressing