Placement of Antibiotic Powder in Wounds During the Emergency Room

NCT03765567 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: HSC20180520HW81XWH-18-2-0074
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

infection; vancomycin; topical antibiotic; antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Deep-space infection rate at prophylaxis site

  The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.

  Within one year of injury date

Secondary Outcomes (4)

• Superficial infection rate requiring post-operative medical intervention

  Within one year of injury date

• Unplanned repeat visit rate

  Within one year of injury date

• Readmission rate for open fracture infection

  Within one year of injury date

• Death rate

  Within one year of injury date

Study Arms (3)

Intervention Arm

EXPERIMENTAL

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.

Drug: Vancomycin

Control Arm

NO INTERVENTION

Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.

Observational Arm

NO 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.

Interventions

Vancomycin DRUG

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

Also known as: NDC (National Drug Code) 67457-340-01, Topical vancomycin, Vancomycin powder

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• hours or less has elapsed from the estimated time of injury to study intervention.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• United States Army Institute of Surgical Research: collaborator
• San Antonio Military Medical Center: collaborator

Study Sites (2)

University Hospital

San Antonio, Texas, 78229, United States

RECRUITING

San Antonio Military Medical Center

San Antonio, Texas, 78234, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Fractures, Open; Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Robert A De Lorenzo, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert A De Lorenzo, MD

CONTACT

210-567-0056; DeLorenzo@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 5, 2018
• Study Start: October 5, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available within one year of study completion.
• Access Criteria: Research data obtained through this study will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. While data will be provided in a timely fashion, the actual timelines of availability of requested data will be specific to the data requested and any special sensitivity of the requested data set.

Locations

US (2)