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Single vs Double Debridement for Joint Infections After Prosthetics

N/A

Waitlist Available

Led By Matthew Abdel, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 5, and 10 years following dair procedure

Awards & highlights

Study Summary

This trial studies two different surgical treatments for joint infections after hip and knee replacements. Comparing single to double debridement, antibiotics, and implant retention.

Who is the study for?

This trial is for English-speaking patients with a recent infection around their hip or knee joint replacement. They must have certain lab results indicating an infection, like positive cultures from the prosthesis or high levels of inflammation markers in blood and tissue. It's not open to those who've had revision surgery or chronic infections lasting more than 4 weeks.Check my eligibility

What is being tested?

Researchers are comparing two surgeries for treating joint infections after hip or knee replacements: one involves a single cleaning procedure while the other uses two planned cleanings. Both include keeping the implant in place and using antibiotics afterwards.See study design

What are the potential side effects?

Potential side effects may include reactions to anesthesia, complications from surgical procedures such as bleeding or further infection, and adverse responses to long-term antibiotic use which can range from stomach upset to more serious conditions like antibiotic resistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 5, and 10 years following dair procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 5, and 10 years following dair procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 5, and 10 years following dair procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Subjects free from failure

Secondary outcome measures

1-year surgical reoperation rate

10-year surgical revision rate

5-year surgical reoperation rate

+6 more

Trial Design

2Treatment groups

Active Control

Group I: Single DAIR Surgery ArmActive Control1 Intervention

Subjects will undergo a single Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.

Group II: Double DAIR Surgery ArmActive Control1 Intervention

Subjects will undergo planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,766,593 Total Patients Enrolled

Matthew Abdel, MDPrincipal InvestigatorMayo Clinic

3 Previous Clinical Trials

756 Total Patients Enrolled

Media Library

Planned Double Debridement, Antibiotics and Implant Retention Clinical Trial Eligibility Overview. Trial Name: NCT05640336 — N/A

Periprosthetic Joint Infection Research Study Groups: Single DAIR Surgery Arm, Double DAIR Surgery Arm

Periprosthetic Joint Infection Clinical Trial 2023: Planned Double Debridement, Antibiotics and Implant Retention Highlights & Side Effects. Trial Name: NCT05640336 — N/A

Planned Double Debridement, Antibiotics and Implant Retention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05640336 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can members of the public participate in this research initiative?

"According to clinicaltrials.gov, this study is not currently accepting participants; the trial was initially published on December 1st 2022 and has had its most recent update on November 28th of that same year. While enrollment for this research project is closed, there are still 780 other trials actively seeking patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Matthew P. Abdel, M.D. 2023. "Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05640336.