Prospective Randomized Evaluation of Emerging Novel Treatments for Infection Prophylaxis in Total Joint Replacement: A Pilot Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 495
- Locations
- 6
- Primary Endpoint
- 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.
Study Overview
Brief Summary
At the end of total joint replacement (TJR) surgery, surgeons wash and clean the surgical wound. This is done to lower the risk of infections. Currently, most surgeons use saline to wash the surgical wound and do not place antibiotics in the wound . However, some recent studies have shown that using povidone-iodine and chlorhexidine-based solutions (both are types of antiseptics) to wash the surgical site and placing antibiotics directly into the wound may be effective in reducing infections in TJR surgery compared to saline and no antibiotics. However, no study has determined which solution is better at reducing the number of infections in patients undergoing TJR. The investigators also do not know if the addition of antibiotics applied to the wound will decrease infections. Currently, there are no surgical guidelines around infection prevention in total joint replacement. A large scale, multi-site, pragmatic 3 x 2 factorial randomized controlled trial is need that compares these six treatment groups. However, before this, a smaller pilot study must be conducted to determine the feasibility of a larger study. PREVENT-iT will address these important gaps in knowledge and clinical practice.
Detailed Description
The investigators propose a pilot study that will determine the feasibility of a definitive trial that compares irrigation fluids and topical antimicrobials to reduce the risk of wound complications requiring reoperation in patients undergoing primary or aseptic revision hip or knee TJR.
In the pilot phase, the investigators will compare three irrigation fluids (povidone-iodine lavage, chlorohexidine lavage, and normal saline) and the investigators will compare the use of vancomycin powder versus no powder in a 3 x 2 factorial RCT design.
Therefore, eligible and consenting participants will be randomized to one of six treatment groups:
- Povidone-iodine lavage and local antibiotics
- Chlorhexidine lavage and local antibiotics
- Normal saline lavage and local antibiotics
- Povidone-iodine lavage with no local antibiotics
- Chlorhexidine lavage with no local antibiotics
- Normal saline lavage with no local antibiotics
Study participants will be assessed at regular intervals in the one year following their TJR. The primary clinical outcome is PWD or PJI requiring reoperation within 90 days of TJR. The secondary clinical outcome is PJI within 12 months of TJR.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The orthopaedic team (including the study coordinators) cannot be blinded to the treatment allocation as the solutions are visually distinguishable and these individuals need to lead the data collection at their clinical site. The participants, the Adjudication Committee Members, and the data analysts will be blinded to the study treatment. Participants may request to be unblinded following the completion of their 12-month visit.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18 years of age or older.
- •Undergoing primary or revision TJR.
- •Informed consent obtained.
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 PJI.
- •Undergoing surgery for a diagnosis of a fracture.
- •Open wounds on affected limb.
- •Undergoing bilateral TJR.
- •Medical contraindication to povidone-iodine.
- •Medical contraindication to chlorhexidine.
- •Medical contraindication to vancomycin.
- •Current or anticipated incarceration.
- •Terminal illness with expected survival less than 90 days.
- •Currently enrolled in a study that does not permit co-enrollment.
- •Unable to obtain informed consent due to language barriers.
- •Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- •Prior enrollment in the trial.
- •Other reason to exclude the patient, as approved by the Methods Centre.
Arms & Interventions
Povidone-iodine Lavage and Local Antibiotics
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.
Intervention: Povidone-Iodine Lavage Solution (Drug)
Povidone-iodine Lavage and Local Antibiotics
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.
Intervention: Topical Antibiotic (Drug)
Chlorhexidine Lavage and Local Antibiotics
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.
Intervention: Chlorhexidine Lavage Solution (Drug)
Chlorhexidine Lavage and Local Antibiotics
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.
Intervention: Topical Antibiotic (Drug)
Normal Saline Lavage and Local Antibiotics
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.
Intervention: Topical Antibiotic (Drug)
Normal Saline Lavage and Local Antibiotics
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.
Intervention: Saline Lavage Solution (Drug)
Povidone-iodine Lavage Solution with no Local Antibiotics
1 litre of 0.35% povidone-iodine lavage solution will be used immediately prior to closure.
Intervention: Povidone-Iodine Lavage Solution (Drug)
Chlorhexidine Lavage Solution with no Local Antibiotics
1 litre of 0.05% chlorhexidine lavage solution will be used immediately prior to closure.
Intervention: Chlorhexidine Lavage Solution (Drug)
Normal Saline Lavage with no Local Antibiotics
1 litre of sterile isotonic saline solution will be used immediately prior to closure.
Intervention: Saline Lavage Solution (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 2 - 2.5 years
Each domain will be interpreted via a "traffic light" approach, in which "green" will indicate moving forward as is with the definitive trial, "yellow" will mean proceeding with some modifications, and "red" will indicate that the definitive trial is not feasible. Feasibility criteria will be monitored over the course of the pilot study and modifications will be made to the protocol during the pilot phase to increase feasibility.
Secondary Outcomes
- Persistent Wound Drainage (PWD) and Periprosthetic Joint Infections (PJI) requiring reoperation(Within 90 days of the Total Joint Replacement Surgery)