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Preliminary results showed that the use of the cloths helped prevent infections.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Control TKA | Sham Comparator | 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. |
|
| Primary Treatment TKA | Active Comparator | Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. |
|
| Revision Treatment TKA | Active Comparator | Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths. |
|
| Revision Control TKA | Sham Comparator | 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. |
|
| Primary Control THA | Sham Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorhexidine impregnated cloths | Other | Pre-operative use of Chlorhexidine cloths night before and morning of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of periprosthetic infection. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Mont, MD | Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement | Principal Investigator |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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|
| Primary Treatment THA | Active Comparator | Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. |
|
| Revision Control THA | Sham Comparator | 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. |
|
| Revision Treatment THA | Active Comparator | Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths. |
|
| Standard of care bathing with antibacterial soap and water | Other | Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery. |
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |