Recruiting

Antibiotic Powder

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT03765567

Conditions

Open Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vancomycin

Study Details

Brief summary:

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.

Conditions

Open Fracture

Study ID

NCT03765567

Start date

Oct 5, 2020

Status verified date

Jul, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
  • Adult 18 years of age or older.
  • Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
  • 24 hours or less has elapsed from the estimated time of injury to study intervention.

Exclusion Criteria:

  • Time from injury > 24 hours.
  • Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
  • Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
  • High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
  • Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
  • Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
  • Prisoners.
  • Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Vancomycin

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Robert A De Lorenzo, MD

210-567-0056DeLorenzo@uthscsa.edu

Locations

University Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Robert DeLorenzo, MD

210-567-4292delorenzo@uthscsa.edu

Stephanie Martinez

210 450-8566martinezs13@uthscsa.edu

Principal Investigator:

Robert A De Lorenzo, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • infection
  • vancomycin
  • topical antibiotic
  • antibiotic prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-08-01.