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Antibiotic

Vancomycin Powder for Fractures (POWDER Trial)

Phase 4
Recruiting
Led By Robert A De Lorenzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
Adult 18 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one year of injury date
Awards & highlights

POWDER Trial Summary

This trial found that vancomycin powder reduces infection-related complications when applied to open fractures in the emergency department.

Who is the study for?
Adults over 18 with open fractures of certain bones who can consent to the study within 24 hours of injury. Excluded are those treated with high-potency antibiotics, allergic to vancomycin, pregnant women, prisoners, and subjects already operated on for the fracture elsewhere.Check my eligibility
What is being tested?
The trial is testing if applying vancomycin powder directly into open fractures in the emergency room can reduce infection-related complications compared to not using it or standard treatments.See study design
What are the potential side effects?
Potential side effects may include allergic reactions specific to vancomycin such as skin rashes or more severe responses. However, since it's applied topically in a wound rather than taken systemically, some common systemic side effects might be less likely.

POWDER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an open fracture in one of my major bones.
Select...
I am 18 years old or older.
Select...
My injury occurred less than 24 hours ago.

POWDER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one year of injury date
This trial's timeline: 3 weeks for screening, Varies for treatment, and within one year of injury date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Deep-space infection rate at prophylaxis site
Secondary outcome measures
Death rate
Readmission rate for open fracture infection
Superficial infection rate requiring post-operative medical intervention
+1 more

POWDER Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.
Group II: Observational ArmActive Control1 Intervention
Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.
Group III: Control ArmActive Control1 Intervention
Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930

Find a Location

Who is running the clinical trial?

San Antonio Military Medical CenterFED
21 Previous Clinical Trials
4,639 Total Patients Enrolled
United States Army Institute of Surgical ResearchFED
29 Previous Clinical Trials
1,568 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
451 Previous Clinical Trials
87,208 Total Patients Enrolled

Media Library

Vancomycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03765567 — Phase 4
Fractures Research Study Groups: Observational Arm, Control Arm, Intervention Arm
Fractures Clinical Trial 2023: Vancomycin Highlights & Side Effects. Trial Name: NCT03765567 — Phase 4
Vancomycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03765567 — Phase 4

Frequently Asked Questions

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

In what situations is Vancomycin typically prescribed?

"Vancomycin is an antibiotic effective at treating afflictions caused by staphylococcal infections, such as enterocolitis due to Staphylococcus aureus."

Answered by AI

How many participants are currently taking part in this clinical research?

"Confirmed. The clinicaltrials.gov database affirms that this medical research endeavor, which was first posted on October 5th 2020, is actively recruiting for participants. Approximately 200 patients need to be recruited from two different locations."

Answered by AI

What risks should be taken into account when utilizing Vancomycin?

"Taking into consideration that it is a Phase 4 study, the safety of Vancomycin was rated 3 out of 3 by Power's team due to its approval for clinical use."

Answered by AI

Is it feasible to become a participant in this research?

"In search of 200 participants, this trial invites those 18 or older and with a fracture to their humerus, radius, ulna, femur, tibia and/or fibula. Notably, eligible individuals must be within 24 hours from the time of injury for study intervention."

Answered by AI

Is the enrollment for this clinical experiment open to those aged 45 or older?

"This research experiment has a strict age requirement, with suitable candidates needing to be between 18 and 89 years old. There are 50 studies available for minors while 213 trials exist specifically designed for individuals over the age of 65."

Answered by AI

Has any prior research been conducted involving Vancomycin?

"At present, 55 clinical trials are being carried out to research Vancomycin. 6 of those studies have reached Phase 3 while most of the rest are located in Jupiter, Florida. In total, 315 medical sites around the world are conducting trials for this drug."

Answered by AI

Does this trial presently accept participants?

"According to information published on clinicaltrials.gov, this medical trial is presently enrolling patients. It was first posted in October 5th 2020 and the details were most recently revised on February 28th 2022."

Answered by AI
~9 spots leftby Jun 2024