Back to resultsA 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).
Primary Purpose
Surgical Incision
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PICO
Aquacel
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Incision
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- Subjects who have participated in this trial previously and who were withdrawn 9 .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 Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single-Use Negative Pressure Wound Therapy
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
Surgical Site Infection
Secondary Outcome Measures
Full Information
NCT ID
NCT03180346
First Posted
June 6, 2017
Last Updated
June 6, 2017
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03180346
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).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2017 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
494 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single-Use Negative Pressure Wound Therapy
Arm Type
Active Comparator
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PICO
Intervention Description
Single Use Negative Pressure Dressing
Intervention Type
Device
Intervention Name(s)
Aquacel
Intervention Description
Occlusive surgical dressing infused with ionized silver
Primary Outcome Measure Information:
Title
Surgical Site Infection
Time Frame
90-day followup following revision surgery
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)
Facility Information:
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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).
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