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



Status:Recruiting
Conditions:Infectious Disease, Hospital, Hospital, Orthopedic, Orthopedic
Therapuetic Areas:Immunology / Infectious Diseases, Orthopedics / Podiatry, Other
Healthy:No
Age Range:22 - Any
Updated:3/27/2019
Start Date:December 5, 2017
End Date:October 2019
Contact:Eric Synatschk, MS
Email:eric.synatschk@acelity.com
Phone:512-662-5943

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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)

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.


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
We found this trial at
18
sites
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Weston, Florida 33331
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1933-1963 Union Boulevard
Bay Shore, New York 11706
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Birmingham, Alabama 35233
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Columbia, Missouri 65203
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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New Albany, Ohio 43054
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New Orleans, Louisiana 70112
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130 East 77th Street
New York, New York 10075
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, New York 10003
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1455 Montreal Road East
Tucker, Georgia 30084
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