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)
Primary Purpose
Surgical Wound Infection
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquacel Ag Surgical Dressing
Single-Use Negative Pressure Wound Therapy (PICO)
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection
Eligibility Criteria
Inclusion Criteria:
- Patient ≥18 years old
- Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
- 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
- Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion Criteria:
- Wounds that require daily inspection
- Active bleeding within the surgical site
- Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
- Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
- Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
- Subjects undergoing primary total joint procedures
- Subjects with a known history of poor compliance with medical treatment
- Subjects who have participated in this trial previously and who were withdrawn 9 .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)
Sites / Locations
- Rothman InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aquacel Ag Surgical Dressing
Single-Use Negative Pressure Wound Therapy (PICO)
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Surgical Site Infection
Secondary Outcome Measures
Full Information
NCT ID
NCT02664168
First Posted
January 22, 2016
Last Updated
April 10, 2018
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT02664168
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Aquacel Ag Surgical Dressing
Arm Type
Active Comparator
Arm Title
Single-Use Negative Pressure Wound Therapy (PICO)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Aquacel Ag Surgical Dressing
Intervention Type
Device
Intervention Name(s)
Single-Use Negative Pressure Wound Therapy (PICO)
Primary Outcome Measure Information:
Title
Incidence of Surgical Site Infection
Time Frame
90 days post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥18 years old
Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
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
Subjects deemed able to understand and comply with study visit schedule and procedures
Exclusion Criteria:
Wounds that require daily inspection
Active bleeding within the surgical site
Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
Subjects undergoing primary total joint procedures
Subjects with a known history of poor compliance with medical treatment
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Morrison, MS
Phone
267-339-7818
Email
tiffany.morrison@rothmaninstitute.com
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Morrison
Phone
267-339-7818
Email
tiffany.morrison@rothmaninstitute.com
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs