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

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ClinicalTrials.gov Identifier: NCT03274466
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Surgical Wound Revision Total Knee Arthroplasty Wounds and Injuries Joint Disease Musculoskeletal Disease Prosthesis-Related Infections Infection Postoperative Complications Pathologic Processes Device: Closed Incision Negative Pressure Therapy (ciNPT) Device: Standard of Care Dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Closed Incision Negative Pressure Therapy (ciNPT)
Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit
Device: Closed Incision Negative Pressure Therapy (ciNPT)
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
Other Names:
  • Prevena Peel & Place
  • Prevena Plus Customizable
  • ActiV.A.C. Therapy Unit
  • Prevena Plus 125 Therapy Unit

Active Comparator: Standard of Care Dressing
Silver impregnated dressing
Device: Standard of Care Dressing
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Other Name: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent




Primary Outcome Measures :
  1. Surgical Site Complications (SSC) [ Time Frame: 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 :
  1. Surgical Site Infection (SSI) (superficial or deep) [ Time Frame: 90 days after TKA revision ]
    90 day subject incidence of any SSI (superficial or deep)

  2. Deep Surgical Site Infection [ Time Frame: 90 days after TKA revision ]
    90 day subject incidence of deep surgical site infection



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274466


Contacts
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Contact: Eric Synatschk, MS 512-662-5943 eric.synatschk@acelity.com
Contact: Anthony Tate 210-515-4060 anthony.tate@acelity.com

Locations
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United States, Alabama
University of Alabama Medical Center Withdrawn
Birmingham, Alabama, United States, 35205
United States, Florida
Cleveland Clinic Recruiting
Weston, Florida, United States, 33331
Contact: Jesus Villa         
United States, Georgia
Emory University Orthopedics & Spine Hospital Recruiting
Tucker, Georgia, United States, 30084
Contact: Jared O'Neal, MPH         
United States, Louisiana
LSU Health Science Center Recruiting
New Orleans, Louisiana, United States, 70006
Contact: Cara J Rowe         
United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Contact: Stacee Clawson, BSN, RN         
United States, New York
Northwell Health - SouthSide Hospital Recruiting
Bay Shore, New York, United States, 11706
Contact: Peter Olivares         
New York University (NYU) Recruiting
New York, New York, United States, 10003
Contact: Ariel Aponte         
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Victoria Tam         
Columbia University Medical Center/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Emma Jennings         
Northwell Health - Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Kristina Dushaj, MA         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Jennifer Friend         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alison Klika, MS         
Joint Implant Surgeons Recruiting
New Albany, Ohio, United States, 43054
Contact: Michael Sneller         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Rebecca Wetzel         
Contact: Erh-Ting Hsu         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Helena Moses         
Contact: Mary Dooley, PhD         
Rothman Institute - Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: John Armstrong         
United States, Texas
Houston Methodist Research Institute Active, not recruiting
Houston, Texas, United States, 77030
Texas Center for Joint Replacement Withdrawn
Plano, Texas, United States, 75093
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 32743
Contact: Melanie Morgan         
Sponsors and Collaborators
KCI USA, Inc.
Investigators
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Principal Investigator: Carlos Higuera, MD The Cleveland Clinic

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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT03274466     History of Changes
Other Study ID Numbers: KCI.PREVENA.2017.01
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Prosthesis-Related Infections
Joint Diseases
Postoperative Complications
Pathologic Processes
Surgical Wound
Wounds and Injuries
Musculoskeletal Diseases