Acute Application of Antibiotic Powder in Open Fracture Wounds

NCT04872400 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 20-29575672
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.

Conditions

Fractures, Open; Wounds and Injuries--Infections; Anti-Bacterial Agents; Fractures, Bone; Extremity Fracture Lower; Extremity Fractures Upper

Keywords

Open fractures; Antibiotic powder; Vancomycin; Tobramycin; Infection; Gustilo; 16S

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection During the Post-operative Follow-up Period

  The percentage of participants who develop an infection at the surgical site following debridement and fixation at the follow up period.

  Within 6 months of injury date

Secondary Outcomes (1)

• Presence of Fracture Nonunion

  Within 1 year of injury date

Study Arms (3)

Control

NO INTERVENTION

Subjects randomized to the Control Arm will receive standard of care open fracture wound care (no powder) by the clinical team.

Vancomycin

EXPERIMENTAL

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.

Drug: Vancomycin

Tobramycin

EXPERIMENTAL

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.

Drug: Tobramycin

Interventions

Vancomycin DRUG

1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.

Vancomycin

Tobramycin DRUG

1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.

Tobramycin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject or proxy willing and able to provide written informed consent.
• Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
• Open extremity fractures
• Time from injury to study intervention 24 hours or less

You may not qualify if:

• Individuals under the age of 18 years or over 80 years
• Type I or IIIC open fractures
• Over 24 hours from time of injury
• Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
• Open fractures distal to the wrist and midfoot
• History of chronic infection in the extremity involved.
• Subjects who are currently pregnant
• Subjects who are Prisoners
• Subjects with a known allergy to vancomycin or tobramycin
• Subjects with a condition or social circumstances that would reduce adherence and follow-up.
• Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Denver Health and Hospital Authority: collaborator

Study Sites (2)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Fractures, Open; Wounds and Injuries; Fractures, Bone; Infections

Interventions

Vancomycin; Tobramycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Nebramycin; Kanamycin; Aminoglycosides; Glycosides

Limitations and Caveats

Study limitations included a small sample size, preventing statistical significance testing between arms. Patient follow-up was hindered by geographic distance from the trauma center. Variations in fracture patterns and size led to potential inconsistencies in antibiotic powder administration and swabbing techniques (e.g., skin flora contamination). Future studies require larger cohorts to confirm the efficacy of local antibiotic powder in orthopedic trauma.

Results Point of Contact

• Title: Nicholas Alfonso, M.D., Principal Investigator
• Organization: University of Colorado - Anschutz Medical Campus

nicholas.alfonso@cuanschutz.edu

303-724-1055

Study Officials

• Nicholas Alfonso, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This will be a single-blind study as only the participants will be blinded to the treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The management of open fractures involves an expedited administration of systemic antibiotics and while effective in reducing the rate of infection, complications from infections are still common following open fractures. This trial aims to evaluate the incidence of surgical site infections using topical vancomycin antibiotic powder or topical tobramycin antibiotic powder in combination with standard of care treatment and to evaluate the effectiveness of both topical antibiotic powders in reducing surgical site infection.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: June 14, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)