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

March 13, 2018 updated by: LifeBridge Health

Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

539

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Primary Control TKA
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.
Other: Standard of care bathing with antibacterial soap and water
Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
Active Comparator: Primary Treatment TKA
Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
Other: chlorhexidine impregnated cloths
Pre-operative use of Chlorhexidine cloths night before and morning of surgery
Active Comparator: Revision Treatment TKA
Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths.
Other: chlorhexidine impregnated cloths
Pre-operative use of Chlorhexidine cloths night before and morning of surgery
Sham Comparator: Revision Control TKA
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.
Other: Standard of care bathing with antibacterial soap and water
Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
Sham Comparator: Primary Control THA
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.
Other: Standard of care bathing with antibacterial soap and water
Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
Active Comparator: Primary Treatment THA
Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
Other: chlorhexidine impregnated cloths
Pre-operative use of Chlorhexidine cloths night before and morning of surgery
Sham Comparator: Revision Control THA
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.
Other: Standard of care bathing with antibacterial soap and water
Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
Active Comparator: Revision Treatment THA
Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
Other: chlorhexidine impregnated cloths
Pre-operative use of Chlorhexidine cloths night before and morning of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of periprosthetic infection.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeBridge Health

Investigators

  • Principal Investigator: Michael A Mont, MD, Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LifeBridgeH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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