Clinical trial NCT03274466: Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Revision Total Knee Arthroplasty
Wounds and Injuries
Joint Disease
Musculoskeletal Disease
Prosthesis-Related Infections
Infection
Postoperative Complications
Pathologic Processes
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-09-07
Enrollment: 294
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Surgical Site Complications (SSC)
timeFrame: within 90 days after TKA revision
Secondary outcomes:
measure: Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
timeFrame: 90 days after TKA revision
measure: Number of Participants With Deep Surgical Site Infection
timeFrame: 90 days after TKA revision
Other outcomes:
measure: Number of Participants With Surgical Site Complication (SSC)
timeFrame: within 90 days after TKA revision
Locations:
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Tucker
country: United States
facility: Emory University Orthopedics & Spine Hospital
state: Georgia
city: New Orleans
country: United States
facility: LSU Health Science Center
state: Louisiana
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Bay Shore
country: United States
facility: Northwell Health - SouthSide Hospital
state: New York
city: New York
country: United States
facility: New York University (NYU)
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Northwell Health - Lenox Hill Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: New Albany
country: United States
facility: Joint Implant Surgeons
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute - Thomas Jefferson University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: The Cleveland Clinic
name: Carlos Higuera, MD
role: PRINCIPAL_INVESTIGATOR
References: