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| Name | Class |
|---|---|
| McMaster University | OTHER |
| Ontario Clinical Oncology Group (OCOG) | OTHER |
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Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-Iodine 0.35% Lavage Solution | Experimental | The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline. |
|
| Povidone-Iodine 0.35% Lavage Solution and Vancomycin | Experimental | The study lavage solution (povidone-iodine) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline. |
|
| Chlorhexidine Gluconate 0.05% Lavage Solution | Experimental | The study lavage solution (chlorhexidine-gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline. |
|
| Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin | Experimental | The study lavage solution (chlorhexidine gluconate) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. The study lavage solution will be a total volume of 1 litre, made with sterile isotonic saline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Drug | 0.05% chlorhexidine gluconate solution for irrigation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of reoperations due to infection | Within 1 year of total joint replacement |
| Measure | Description | Time Frame |
|---|---|---|
| The number of non-operative surgical site infections requiring antibiotics for treatment. | Within 1 year of total joint replacement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Maharaj, MSc | Contact | 905-521-2100 | 43814 | maharajli@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Thomas J Wood, MD, FRCSC | Hamilton Health Sciences / McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences - Juravinski Hospital and Cancer Centre | Recruiting | Hamilton | Ontario | L8V 1C3 | Canada |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D014640 | Vancomycin |
| D011206 | Povidone-Iodine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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|
| Saline Lavage Solution | Active Comparator | The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. The study lavage solution will be a total volume of 1 litre. |
|
| Saline Lavage Solution and Vancomycin | Experimental | The study lavage solution (saline) is the final lavage and is to be poured in and left for 3 minutes then removed by suction. Two grams of vancomycin is applied to the deep joint (to arthrotomy in knee and deep to fascia in hip) following removal of the study lavage solution and immediately prior to closure. |
|
| Vancomycin Hydrochloride | Drug | 2 grams of topical vancomycin hydrochloride added to the wound |
|
| Povidone-Iodine | Other | 0.35% povidone-iodine solution for irrigation |
|
| Saline | Other | saline for irrigation |
|
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |