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Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths. (SAGE)

Primary Purpose

Osteoarthritis, Infection

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
chlorhexidine impregnated cloths
Standard of care bathing with antibacterial soap and water
Sponsored by
LifeBridge Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring infection; arthroplasty; chlorhexidine; hip; knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Joint replacement surgery for any reason
  • 18 years or older

Exclusion Criteria:

  • unable to comply with study requirements
  • were pregnant
  • were under the age of 18 years
  • medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
  • received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
  • chronic hepatitis B or C infection
  • had an infection in or around the joint requiring surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Sham Comparator

    Active Comparator

    Active Comparator

    Sham Comparator

    Sham Comparator

    Active Comparator

    Sham Comparator

    Active Comparator

    Arm Label

    Primary Control TKA

    Primary Treatment TKA

    Revision Treatment TKA

    Revision Control TKA

    Primary Control THA

    Primary Treatment THA

    Revision Control THA

    Revision Treatment THA

    Arm Description

    Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

    Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.

    Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths.

    Patients undergoing a second or revision total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

    Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

    Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.

    Patients undergoing a second or revision total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

    Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.

    Outcomes

    Primary Outcome Measures

    The incidence of periprosthetic infection.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2015
    Last Updated
    March 13, 2018
    Sponsor
    LifeBridge Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02469311
    Brief Title
    Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.
    Acronym
    SAGE
    Official Title
    Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Preliminary results showed that the use of the cloths helped prevent infections.
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LifeBridge Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.
    Detailed Description
    Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Infection
    Keywords
    infection; arthroplasty; chlorhexidine; hip; knee

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    539 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Primary Control TKA
    Arm Type
    Sham Comparator
    Arm Description
    Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
    Arm Title
    Primary Treatment TKA
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
    Arm Title
    Revision Treatment TKA
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths.
    Arm Title
    Revision Control TKA
    Arm Type
    Sham Comparator
    Arm Description
    Patients undergoing a second or revision total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
    Arm Title
    Primary Control THA
    Arm Type
    Sham Comparator
    Arm Description
    Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
    Arm Title
    Primary Treatment THA
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
    Arm Title
    Revision Control THA
    Arm Type
    Sham Comparator
    Arm Description
    Patients undergoing a second or revision total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.
    Arm Title
    Revision Treatment THA
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
    Intervention Type
    Other
    Intervention Name(s)
    chlorhexidine impregnated cloths
    Intervention Description
    Pre-operative use of Chlorhexidine cloths night before and morning of surgery
    Intervention Type
    Other
    Intervention Name(s)
    Standard of care bathing with antibacterial soap and water
    Intervention Description
    Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
    Primary Outcome Measure Information:
    Title
    The incidence of periprosthetic infection.
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Joint replacement surgery for any reason 18 years or older Exclusion Criteria: unable to comply with study requirements were pregnant were under the age of 18 years medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment; chronic hepatitis B or C infection had an infection in or around the joint requiring surgery.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael A Mont, MD
    Organizational Affiliation
    Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.

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