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

Not Applicable

Completed

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

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

Registration Number: NCT03274466

Lead Sponsor: KCI USA, Inc

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 294

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Dressing	Standard of Care Dressing	Silver impregnated dressing
Closed Incision Negative Pressure Therapy (ciNPT)	Closed Incision Negative Pressure Therapy (ciNPT)	Prevena Peel \& Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit

Primary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Site Complications (SSC)	within 90 days after TKA revision	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Deep Surgical Site Infection	90 days after TKA revision	90 day subject incidence of deep surgical site infection
Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)	90 days after TKA revision	90 day subject incidence of any SSI (superficial or deep)

Trial Locations

Locations (16): Joint Implant Surgeons
🇺🇸
New Albany, Ohio, United States
Houston Methodist Research Institute
🇺🇸
Houston, Texas, United States
New York University (NYU)
🇺🇸
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸
New York, New York, United States
LSU Health Science Center
🇺🇸
New Orleans, Louisiana, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Northwell Health - SouthSide Hospital
🇺🇸
Bay Shore, New York, United States
Northwell Health - Lenox Hill Hospital
🇺🇸
New York, New York, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Rothman Institute - Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Emory University Orthopedics & Spine Hospital
🇺🇸
Tucker, Georgia, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
University of Missouri Health Care
🇺🇸
Columbia, Missouri, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States