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Status:

COMPLETED

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

Lead Sponsor:

KCI USA, Inc

Collaborating Sponsors:

3M

Conditions:

Surgical Wound

Revision Total Knee Arthroplasty

Eligibility:

All Genders

22+ years

Phase:

NA

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 c...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

December 5 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 19 2019

Estimated Enrollment :

294 Patients enrolled

Trial Details

Trial ID

NCT03274466

Start Date

December 5 2017

End Date

December 19 2019

Last Update

October 16 2024

Active Locations (17)

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Page 1 of 5 (17 locations)

1

Cleveland Clinic

Weston, Florida, United States, 33331

2

Emory University Orthopedics & Spine Hospital

Tucker, Georgia, United States, 30084

3

LSU Health Science Center

New Orleans, Louisiana, United States, 70006

4

University of Missouri Health Care

Columbia, Missouri, United States, 65212