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Wound Lavage Solutions for Infection Prevention in Joint Replacement Surgery (PREVENT-IT Trial)
Phase 3
Waitlist Available
Led By Thomas Wood, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients 18 years of age or older.
Undergoing primary or revision TJR.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 - 2.5 years
Awards & highlights
PREVENT-IT Trial Summary
This trial will compare different solutions for washing surgical wounds and placing antibiotics in the wound to see which combination is most effective in preventing infection in patients undergoing total joint replacement surgery.
Who is the study for?
This trial is for adults over 18 who are having their first or a revision total joint replacement (TJR) surgery and can give informed consent. It's not for those with bilateral TJR, allergies to specific antiseptics or antibiotics, current infections at the surgery site, open wounds on the limb, recent antibiotic use, prior PJI history, terminal illness with less than 90 days expected survival, or other exclusions by study personnel.Check my eligibility
What is being tested?
The PREVENT-iT pilot study tests if washing surgical wounds with povidone-iodine or chlorhexidine solutions and applying topical antibiotics after TJR can prevent infections better than saline without antibiotics. This smaller study will help decide if a larger trial should be done to establish new surgical guidelines.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the antiseptic solutions (chlorhexidine and povidone-iodine) or topical antibiotics used in the wound. These could cause skin irritation or more severe allergy symptoms.
PREVENT-IT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for or have had a total joint replacement surgery.
PREVENT-IT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 - 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 - 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of a Definitive Trial based on the following criteria domains: 1) Participant Enrollment, 2) Administration of Treatments, 3) Data Collection Methods, and 4)Compliance with the Protocol.
Secondary outcome measures
Persistent Wound Drainage (PWD) and Periprosthetic Joint Infections (PJI) requiring reoperation
Other outcome measures
Tertiary/exploratory Outcome: Periprosthetic Joint Infections (PJI)
PREVENT-IT Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Povidone-iodine Lavage and Local AntibioticsExperimental Treatment2 Interventions
1 litre of 0.35% povidone-iodine lavage solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure.
Group II: Povidone-iodine Lavage Solution with no Local AntibioticsExperimental Treatment1 Intervention
1 litre of 0.35% povidone-iodine lavage solution will be used immediately prior to closure.
Group III: Normal Saline Lavage and Local AntibioticsExperimental Treatment2 Interventions
1 litre of sterile isotonic saline solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure.
Group IV: Chlorhexidine Lavage and Local AntibioticsExperimental Treatment2 Interventions
1 litre of 0.05% chlorhexidine lavage solution will be used. 2 grams of Vancomycin antibiotic powder will be applied to the deep joint (deep to fascia) following lavage solution and immediately prior to closure.
Group V: Chlorhexidine Lavage Solution with no Local AntibioticsExperimental Treatment1 Intervention
1 litre of 0.05% chlorhexidine lavage solution will be used immediately prior to closure.
Group VI: Normal Saline Lavage with no Local AntibioticsActive Control1 Intervention
1 litre of sterile isotonic saline solution will be used immediately prior to closure.
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,493 Total Patients Enrolled
McMaster UniversityOTHER
880 Previous Clinical Trials
2,597,328 Total Patients Enrolled
Thomas Wood, MDPrincipal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very serious illness and are not expected to live longer than 90 days.I cannot give informed consent because I do not understand the language.The Methods Center has approved other reasons to exclude you from the study.I have had a joint infection in the past.I have open wounds on the limb affected by my condition.I have taken antibiotics within two weeks before my joint replacement surgery.I am having both of my joints replaced.You cannot use povidone-iodine due to a medical condition.I am having surgery for a broken bone.You have a medical condition that makes it unsafe for you to use chlorhexidine.I am 18 years old or older.I am scheduled for or have had a total joint replacement surgery.I have an infection at or near my joint replacement site.I cannot take vancomycin due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Saline Lavage and Local Antibiotics
- Group 2: Povidone-iodine Lavage and Local Antibiotics
- Group 3: Povidone-iodine Lavage Solution with no Local Antibiotics
- Group 4: Normal Saline Lavage with no Local Antibiotics
- Group 5: Chlorhexidine Lavage and Local Antibiotics
- Group 6: Chlorhexidine Lavage Solution with no Local Antibiotics
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the most common use for Topical Antibiotic?
"Topical Antibiotic can cure and disinfect wounds as well as treat throat injuries."
Answered by AI
Has the FDA cleared Topical Antibiotic for use?
"Topical Antibiotic has been given a safety score of 3. This is because it is a Phase 3 trial, meaning that there is some data to support its efficacy, as well as multiple rounds of data to support its safety."
Answered by AI
Do we have any precedent for using this Topical Antibiotic?
"As of now, there are 29 ongoing clinical trials studying the effects of Topical Antibiotic. 4 of those trials have progressed to Phase 3. The majority of those trials are taking place in Greenville, South carolina, but there are 118 locations across the country running these sorts of tests."
Answered by AI
Are investigators still enrolling patients for this research?
"The latest information available on clinicaltrials.gov shows that this study is still recruiting patients. The trial was originally posted on March 11th, 2022 and was last updated on July 13th, 2022."
Answered by AI
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