Placement of Antibiotic Powder in Wounds During the Emergency Room

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT03765567
Phase
PHASE4
Status
Recruiting
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Conditions

  • Open Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Vancomycin — DRUG
    2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.

Study Details

This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.

Key Dates

Start date
Oct 5, 2020
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Arm
    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.
  • No Intervention: Control Arm
    Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.
  • No Intervention: Observational Arm
    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.

Primary Outcome Measure

Deep-space infection rate at prophylaxis site [ Time Frame: Within one year of injury date ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
San Antonio Military Medical CenterSan AntonioTexas78234
Steven G Schauer, DO
[email protected]
Steven G Schauer, DO (PRINCIPAL_INVESTIGATOR)
University HospitalSan AntonioTexas78229
Robert DeLorenzo, MD
[email protected]
210-567-4292
Stephanie Martinez
[email protected]
210 450-8566
Robert A De Lorenzo, MD (PRINCIPAL_INVESTIGATOR)

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