Evaluation of Emerging New Treatments for Infection Prevention in Total Joint Replacement

NCT05084378 | Completed Phase 3 DMC

• 1 other identifier: PREVENT-IT
• Study Type: interventional
• Target: 495
• Locations: 2 countries
• Sites: 6

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.

Conditions

Periprosthetic Joint Infection; Draining Wound

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  2 - 2.5 years

Secondary Outcomes (1)

• Persistent Wound Drainage (PWD) and Periprosthetic Joint Infections (PJI) requiring reoperation

  Within 90 days of the Total Joint Replacement Surgery

Other Outcomes (1)

• Tertiary/exploratory Outcome: Periprosthetic Joint Infections (PJI)

  Within 12 months of the Total Joint Replacement Surgery

Study Arms (6)

Povidone-iodine Lavage and Local Antibiotics

EXPERIMENTAL

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.

Drug: Povidone-Iodine Lavage Solution; Drug: Topical Antibiotic

Chlorhexidine Lavage and Local Antibiotics

EXPERIMENTAL

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.

Drug: Chlorhexidine Lavage Solution; Drug: Topical Antibiotic

Normal Saline Lavage and Local Antibiotics

EXPERIMENTAL

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.

Drug: Topical Antibiotic; Drug: Saline Lavage Solution

Povidone-iodine Lavage Solution with no Local Antibiotics

EXPERIMENTAL

1 litre of 0.35% povidone-iodine lavage solution will be used immediately prior to closure.

Drug: Povidone-Iodine Lavage Solution

Chlorhexidine Lavage Solution with no Local Antibiotics

EXPERIMENTAL

1 litre of 0.05% chlorhexidine lavage solution will be used immediately prior to closure.

Drug: Chlorhexidine Lavage Solution

Normal Saline Lavage with no Local Antibiotics

ACTIVE COMPARATOR

1 litre of sterile isotonic saline solution will be used immediately prior to closure.

Drug: Saline Lavage Solution

Interventions

Povidone-Iodine Lavage Solution DRUG

0.35% povidone-iodine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.35% povidone-iodine and sterile isotonic saline solution may also be used.

Povidone-iodine Lavage Solution with no Local Antibiotics; Povidone-iodine Lavage and Local Antibiotics

Chlorhexidine Lavage Solution DRUG

0.05% chlorhexidine solution mixed with 1 litre of sterile isotonic saline solution. Commercially available products with 0.05% chlorhexidine and sterile isotonic saline may also be used.

Chlorhexidine Lavage Solution with no Local Antibiotics; Chlorhexidine Lavage and Local Antibiotics

Topical Antibiotic DRUG

2 grams Vancomycin powder

Chlorhexidine Lavage and Local Antibiotics; Normal Saline Lavage and Local Antibiotics; Povidone-iodine Lavage and Local Antibiotics

Saline Lavage Solution DRUG

1 litre of sterile isotonic saline

Normal Saline Lavage and Local Antibiotics; Normal Saline Lavage with no Local Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older.
• Undergoing primary or revision TJR.
• Informed consent obtained.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (6)

St. Joseph's Healthcare

Hamilton, Ontario, L8N4A6, Canada

Location

Hamilton Health Sciences- Juravinkski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Montreal General Hospital

Montreal, Quebec, Canada

Location

St. Mary's Hospital

Montreal, Quebec, Canada

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Thomas Wood, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: October 19, 2021
• Study Start: March 11, 2022
• Primary Completion: August 4, 2024
• Study Completion: October 28, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); CA (4)