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

NCT05084378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 495

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

DRUG

Povidone-Iodine Lavage Solution

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.

DRUG

Chlorhexidine Lavage Solution

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.

DRUG

Topical Antibiotic

2 grams Vancomycin powder

DRUG

Saline Lavage Solution

1 litre of sterile isotonic saline

Sponsors & Collaborators

Principal Investigators

  • Thomas Wood, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2024-08-04
Completion
2024-10-28

Countries

  • Canada
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084378 on ClinicalTrials.gov