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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274466
Recruitment Status : Completed
First Posted : September 7, 2017
Results First Posted : February 10, 2021
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
3M

Tracking Information
First Submitted Date  ICMJE September 5, 2017
First Posted Date  ICMJE September 7, 2017
Results First Submitted Date  ICMJE November 11, 2020
Results First Posted Date  ICMJE February 10, 2021
Last Update Posted Date August 1, 2022
Actual Study Start Date  ICMJE December 5, 2017
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
Number of Participants With 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
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 hemotoma requiring drainage or surgery
  • Skin necrosis
  • Continued drainage at the time of dressing removal
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2021)
  • Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) [ Time Frame: 90 days after TKA revision ]
    90 day subject incidence of any SSI (superficial or deep)
  • Number of Participants With Deep Surgical Site Infection [ Time Frame: 90 days after TKA revision ]
    90 day subject incidence of deep surgical site infection
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
  • Surgical Site Infection (SSI) (superficial or deep) [ Time Frame: 90 days after TKA revision ]
    90 day subject incidence of any SSI (superficial or deep)
  • Deep Surgical Site Infection [ Time Frame: 90 days after TKA revision ]
    90 day subject incidence of deep surgical site infection
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2021)
Number of Participants With Surgical Site Complication (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 the following:
  • Superficial Surgical Site Infection (SSI)
  • Deep SSI
  • Full thickness skin dehiscence
  • Seroma or hematoma requiring drainage or surgery
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgical Wound
  • Revision Total Knee Arthroplasty
  • Wounds and Injuries
  • Joint Disease
  • Musculoskeletal Disease
  • Prosthesis-Related Infections
  • Infection
  • Postoperative Complications
  • Pathologic Processes
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Closed Incision Negative Pressure Therapy (ciNPT)
    Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit
    Intervention: Device: Closed Incision Negative Pressure Therapy (ciNPT)
  • Active Comparator: Standard of Care Dressing
    Silver impregnated dressing
    Intervention: Device: Standard of Care Dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2019)
294
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)
440
Actual Study Completion Date  ICMJE December 19, 2019
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03274466
Other Study ID Numbers  ICMJE KCI.PREVENA.2017.01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party 3M
Original Responsible Party Same as current
Current Study Sponsor  ICMJE 3M
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Higuera, MD The Cleveland Clinic
PRS Account 3M
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP