Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)

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: NCT02664168
Recruitment Status : Unknown
Verified April 2018 by Rothman Institute Orthopaedics.
Recruitment status was:  Recruiting
First Posted : January 26, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE January 22, 2016
First Posted Date  ICMJE January 26, 2016
Last Update Posted Date April 12, 2018
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January¬†25,¬†2016)
Incidence of Surgical Site Infection [ Time Frame: 90 days post-op ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)
Official Title  ICMJE A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)
Brief Summary The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a revision TKA and THA who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. Patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Condition  ICMJE Surgical Wound Infection
Intervention  ICMJE
  • Device: Aquacel Ag Surgical Dressing
  • Device: Single-Use Negative Pressure Wound Therapy (PICO)
Study Arms  ICMJE
  • Active Comparator: Aquacel Ag Surgical Dressing
    Intervention: Device: Aquacel Ag Surgical Dressing
  • Active Comparator: Single-Use Negative Pressure Wound Therapy (PICO)
    Intervention: Device: Single-Use Negative Pressure Wound Therapy (PICO)
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 Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient ≥18 years old
  2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
  3. Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
  4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
  5. Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion Criteria:

  1. Wounds that require daily inspection
  2. Active bleeding within the surgical site
  3. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
  4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
  5. Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
  6. Subjects undergoing primary total joint procedures
  7. Subjects with a known history of poor compliance with medical treatment
  8. Subjects who have participated in this trial previously and who were withdrawn 9 . Subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT02664168
Other Study ID Numbers  ICMJE 2016Jpar01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rothman Institute Orthopaedics
Study Sponsor  ICMJE Rothman Institute Orthopaedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date April 2018

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