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Anti-bacterial

Vancomycin for Wound Infection (APOW Trial)

Phase 4
Waitlist Available
Led By Nicholas Alfonso, MD
Research Sponsored by University of Colorado, Denver
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 within 6 months of injury date
Awards & highlights

APOW Trial Summary

This trial is testing whether using Vancomycin or Tobramycin powder on open fracture wounds can help reduce the rate of infection.

Eligible Conditions
  • Wound Infections
  • Arm Fractures
  • Broken Bones
  • Lower Extremity Fractures
  • Fractures
  • Antibiotics

APOW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 months of injury date
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months 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
Incidence of surgical site infection during the post-operative follow-up period
Secondary outcome measures
Presence of bacterial species commonly attributed to surgical site infections based on would cultures including: Staph, enterococcus, acinetobacter, enterobacter, e. coli, klebsiella, and pseudomonas
Shannon's index measure of bacterial diversity based on wound cultures
Simpson index measure of bacterial diversity based on the wound cultures

APOW Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: VancomycinExperimental Treatment1 Intervention
Subjects randomized to the Intervention arm will receive standard of care plus 1 gram of vancomycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
Group II: TobramycinExperimental Treatment1 Intervention
Subjects randomized to the Intervention arm will receive standard of care plus 1.2 grams of tobramycin powder applied topically to the wound bed before the dressing is applied. Intervention will occur in the emergency room prior to surgical intervention.
Group III: ControlActive Control1 Intervention
Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved
Tobramycin
FDA approved

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,731 Previous Clinical Trials
2,144,577 Total Patients Enrolled
Denver Health and Hospital AuthorityOTHER
101 Previous Clinical Trials
400,377 Total Patients Enrolled
Nicholas Alfonso, MDPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

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

Are there currently vacancies for this experiment?

"Affirmative. Clinicaltrials.gov has documented that the trial, which was originally posted on June 14th 2021, is actively seeking participants. Specifically, they are looking to recruit 120 volunteers from two different locations."

Answered by AI

What is the current count of individuals enrolled in this clinical trial?

"Affirmative. The clinical trial in question was first advertised on June 14th 2021 and subsequently modified most recently on August 17th 2021 according to the information found on clinicaltrials.gov. This study is currently recruiting for 120 patients across 2 locations."

Answered by AI

Could you explain the various experiments that have been conducted with Vancomycin?

"Currently, there are 62 active clinical trials investigating the effects of Vancomycin with 9 in Phase 3. While Jupiter, Florida has a higher concentration of research projects related to this medication, it is being trialled at 325 separate locations across the globe."

Answered by AI

Is this research protocol open to participants aged 30 and above?

"In order to take part in this medical trial, patients must fit the age range of 18 - 80. Notably, there are 201 clinical trials for individuals younger than 18 and 936 studies specifically targeting those above 65 years old."

Answered by AI

Does this research contain any precedent-setting elements?

"Since its inception in 2010, Vancomycin has been the focus of 62 ongoing trials which span 21 nations and 158 cities. The original experiment was funded by Erempharma with 12 participants that would eventually lead to a N/A drug approval."

Answered by AI

Can I take part in this clinical experiment?

"This medical investigation is recruiting 120 individuals with fractures, aged 18 to 80. Crucially, those interested must agree to give written consent; be in the specified age range; have a Gustilo Type II, IIIA or IIIB open fracture that requires debridement and internal fixation; an extremity open fracture occurring 24 hours before intervention at most."

Answered by AI

In what conditions is Vancomycin commonly utilized?

"Vancomycin is typically used to combat bacterial infections, though it may also be effective against burkholderia cepacia infection, eye maladies, and ocular microbial illnesses."

Answered by AI

Is Vancomycin a safe medication for patients to use?

"There is an abundance of research affirming its safety, so the team rated vancomycin at a 3 on the risk scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Acute Application of Antibiotic Powder in Open Fracture Wounds
2021. "Acute Application of Antibiotic Powder in Open Fracture Wounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04872400.
~5 spots leftby Apr 2025
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