Recruiting PHASE3 Periprosthetic Joint Infection

New treatment option for Periprosthetic Joint Infection

Official title Infection Prophylaxis in Total Joint Replacement

ClinicalTrials.gov ID: NCT06126614

What this study is testing

What is Chlorhexidine Gluconate?

Chlorhexidine Gluconate is an investigational medicine, being studied as a potential treatment for periprosthetic joint infection.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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.

You likely can't join 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 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Hamilton, Ontario, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.