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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)

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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

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

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: Aquacel Ag Surgical Dressing Device: Single-Use Negative Pressure Wound Therapy (PICO) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: 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)
Study Start Date : January 2016
Estimated Primary Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aquacel Ag Surgical Dressing Device: Aquacel Ag Surgical Dressing
Active Comparator: Single-Use Negative Pressure Wound Therapy (PICO) Device: Single-Use Negative Pressure Wound Therapy (PICO)



Primary Outcome Measures :
  1. Incidence of Surgical Site Infection [ Time Frame: 90 days post-op ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02664168


Contacts
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Contact: Tiffany Morrison, MS 267-339-7818 tiffany.morrison@rothmaninstitute.com

Locations
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United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Tiffany Morrison    267-339-7818    tiffany.morrison@rothmaninstitute.com   
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02664168    
Other Study ID Numbers: 2016Jpar01
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Wounds and Injuries
Surgical Wound
Postoperative Complications
Pathologic Processes
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents