Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
21006 participants
INTERVENTIONAL
2024-05-07
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Povidone-Iodine 0.35% Lavage Solution
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% povidone-iodine solution for irrigation
Povidone-Iodine 0.35% Lavage Solution and Vancomycin
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.
Vancomycin Hydrochloride
2 grams of topical vancomycin hydrochloride added to the wound
Povidone-Iodine
0.35% povidone-iodine solution for irrigation
Chlorhexidine Gluconate 0.05% Lavage Solution
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% chlorhexidine gluconate solution for irrigation
Chlorhexidine Gluconate 0.05% Lavage Solution and Vancomycin
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.
Chlorhexidine Gluconate
0.05% chlorhexidine gluconate solution for irrigation
Vancomycin Hydrochloride
2 grams of topical vancomycin hydrochloride added to the wound
Saline Lavage Solution
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
saline for irrigation
Saline Lavage Solution and Vancomycin
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
2 grams of topical vancomycin hydrochloride added to the wound
Saline
saline for irrigation
Interventions
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Chlorhexidine Gluconate
0.05% chlorhexidine gluconate solution for irrigation
Vancomycin Hydrochloride
2 grams of topical vancomycin hydrochloride added to the wound
Povidone-Iodine
0.35% povidone-iodine solution for irrigation
Saline
saline for irrigation
Eligibility Criteria
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Inclusion Criteria
2. Undergoing primary or aseptic revision TJR.
3. No contraindications to study interventions.
4. Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.
Exclusion Criteria
2. Chronic or acute infection at or near the TJR site.
3. Prior history of periprosthetic joint infection including any reoperation due to infection.
4. Undergoing surgery for a diagnosis of a fracture.
5. Open infected wounds on affected limb.
6. Undergoing bilateral TJR.
7. Currently enrolled in a study that does not permit co-enrollment.
8. Prior enrollment in the trial including the pilot study
9. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
18 Years
ALL
No
Sponsors
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McMaster University
OTHER
Ontario Clinical Oncology Group (OCOG)
OTHER
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Thomas J Wood, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences / McMaster University
Locations
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Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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PiT-2023
Identifier Type: -
Identifier Source: org_study_id
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