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Clinical Trials/NCT06126614
NCT06126614
Recruiting
Phase 3

Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement (PREVENT-iT)

Hamilton Health Sciences Corporation1 site in 1 country21,006 target enrollmentMay 7, 2024

Overview

Phase
Phase 3
Intervention
Povidone-Iodine
Conditions
Periprosthetic Joint Infection
Sponsor
Hamilton Health Sciences Corporation
Enrollment
21006
Locations
1
Primary Endpoint
The number of reoperations due to infection
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2024
End Date
November 2028
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years of age or older.
  • Undergoing primary or aseptic revision TJR.
  • No contraindications to study interventions.
  • Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Exclusion Criteria

  • Received antibiotics for any reason in the two weeks prior to their TJR.
  • Chronic or acute infection at or near the TJR site.
  • Prior history of periprosthetic joint infection including any reoperation due to infection.
  • Undergoing surgery for a diagnosis of a fracture.
  • Open infected wounds on affected limb.
  • Undergoing bilateral TJR.
  • Currently enrolled in a study that does not permit co-enrollment.
  • Prior enrollment in the trial including the pilot study
  • Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.

Arms & Interventions

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.

Intervention: Povidone-Iodine

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.

Intervention: Vancomycin Hydrochloride

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.

Intervention: Povidone-Iodine

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.

Intervention: Chlorhexidine Gluconate

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.

Intervention: Chlorhexidine Gluconate

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.

Intervention: Vancomycin Hydrochloride

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.

Intervention: Saline

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.

Intervention: Vancomycin Hydrochloride

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.

Intervention: Saline

Outcomes

Primary Outcomes

The number of reoperations due to infection

Time Frame: Within 1 year of total joint replacement

Secondary Outcomes

  • The number of non-operative surgical site infections requiring antibiotics for treatment.(Within 1 year of total joint replacement)

Study Sites (1)

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