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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection, Osteoarthritis

Intervention / Treatment
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* Other: chlorhexidine impregnated cloths
* Other: Standard of care bathing with antibacterial soap and water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of periprosthetic infection. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection; arthroplasty; chlorhexidine; hip; knee