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History of Changes for Study: NCT03180346
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).
Latest version (submitted June 6, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 6, 2017 None (earliest Version on record)
Comparison Format:

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Study NCT03180346
Submitted Date:  June 6, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 16Chen02
Brief 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).
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).
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Unknown status [Previously: Enrolling by invitation]
Study Start: March 21, 2017
Primary Completion: March 2020 [Anticipated]
Study Completion: March 2021 [Anticipated]
First Submitted: June 6, 2017
First Submitted that
Met QC Criteria:
June 6, 2017
First Posted: June 8, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 6, 2017
Last Update Posted: June 8, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: The primary aim of this study is to determine if the SSI rate following revision total hip and knee arthroplasty is reduced in patients treated with the PICO device compared to patients with traditional postoperative dressings. Our secondary goals include; comparing the amount of wound drainage, rate of resolution of wound drainage, length of hospital stay, functional outcomes, and economic implications of wound drainage and SSI after revision arthroplasty comparing PICO and traditional dressings.
Detailed Description:
Open or close this module Conditions
Conditions: Surgical Incision
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 494 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Single-Use Negative Pressure Wound Therapy Device: PICO
Single Use Negative Pressure Dressing
Active Comparator: Standard of Care Device: Aquacel
Occlusive surgical dressing infused with ionized silver
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Surgical Site Infection
[ Time Frame: 90-day followup following revision surgery ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Locations: United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19148
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services