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Antibiotic

Antibiotic Powder for Open Fractures

Q: Are the protocols of this study limited to adults 25 and older?

According to the parameters outlined in this clinical trial, individuals within the age range of 18-90 are eligible for participation. Furthermore, there are 190 studies specifically designed for those under 18 and 613 focused on participants over 65 years old.

Q: Are there any open slots left for enrollment in this experiment?

According to clinicaltrials.gov, recruitment for this trial has concluded; it was initially posted on March 27th 2023 and the last update was May 4th 2023. Despite no longer accepting candidates, there are 774 other medical studies actively recruiting patients at present.

Q: To whom is participation in the experiment accessible?

Participation in this trial necessitates that the candidate has an infection and is aged between 18 and 90. At present, there are 50 openings for suitable applicants.

Phase < 1

Waitlist Available

Led By Justin Haller, M.D.

Research Sponsored by University of Utah

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 6-months post-operative

Awards & highlights

Study Summary

This trial will study the effect of a new treatment for open fracture healing, comparing it to the current standard of care.

Who is the study for?

This trial is for patients with open fractures of specific bones (like the heel, shinbone, or thigh bone) and a moderate to severe injury grade. They must be able to give consent in the emergency department. It's not for those allergic to vancomycin or tobramycin, have advanced kidney disease, are pregnant, or refuse participation.Check my eligibility

What is being tested?

The study aims to compare infection rates between two groups: one receiving standard care antibiotics and another getting a combination of vancomycin and tobramycin powder. Each group will have 25 patients randomly assigned and followed up for six months post-surgery.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to antibiotics used, local wound irritation at the site where medications are applied directly into the fracture area during surgery, and possible impact on kidney function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post-operative for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percent (%) negative deep tissue infections.

Percent (%) positive deep tissue infections.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vancomycin and TobramycinExperimental Treatment1 Intervention

One-time dosage of topical vancomycin (1 gram) and tobramycin (1.2 grams) powder.

Group II: Standard of care prophylactic antibioticsActive Control1 Intervention

Standard irrigation and IV, cephalosporin, 2-grams, intravenous (IV), or standard irrigation and IV, clindamycin (900mg) / vancomycin (20mg/kg), intravenous (IV) for patients with cephalosporin allergies.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,580 Total Patients Enrolled

13 Trials studying Infections

9,545 Patients Enrolled for Infections

Justin Haller, M.D.Principal InvestigatorUniversity of Utah Orthopaedics

2 Previous Clinical Trials

130 Total Patients Enrolled

Media Library

Cephalosporin or clindamycin/vancomycin antibiotics. (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05849090 — Phase < 1

Infections Research Study Groups: Standard of care prophylactic antibiotics, Vancomycin and Tobramycin

Infections Clinical Trial 2023: Cephalosporin or clindamycin/vancomycin antibiotics. Highlights & Side Effects. Trial Name: NCT05849090 — Phase < 1

Cephalosporin or clindamycin/vancomycin antibiotics. (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05849090 — Phase < 1

Frequently Asked Questions

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

Are the protocols of this study limited to adults 25 and older?

"According to the parameters outlined in this clinical trial, individuals within the age range of 18-90 are eligible for participation. Furthermore, there are 190 studies specifically designed for those under 18 and 613 focused on participants over 65 years old."

Answered by AI

Are there any open slots left for enrollment in this experiment?

"According to clinicaltrials.gov, recruitment for this trial has concluded; it was initially posted on March 27th 2023 and the last update was May 4th 2023. Despite no longer accepting candidates, there are 774 other medical studies actively recruiting patients at present."

Answered by AI

To whom is participation in the experiment accessible?

"Participation in this trial necessitates that the candidate has an infection and is aged between 18 and 90. At present, there are 50 openings for suitable applicants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vancomycin and Tobramycin Powder Use in Acute Open Fractures

Justin Haller 2023. "Vancomycin and Tobramycin Powder Use in Acute Open Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05849090.

All > Infectious Disease