Placement of Antibiotic Powder in Wounds During the Emergency Room

NCT ID: NCT03765567

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2027-07-31

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.

Detailed Description

Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.

Conditions

Open Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

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

Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vancomycin

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

Intervention Type: DRUG

Other Intervention Names

NDC (National Drug Code) 67457-340-01; Topical vancomycin; Vancomycin powder

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: collaborator

San Antonio Military Medical Center

FED

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert A De Lorenzo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University Hospital

San Antonio, Texas, United States

Site Status: RECRUITING

San Antonio Military Medical Center

San Antonio, Texas, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Robert A De Lorenzo, MD

Role: CONTACT

DeLorenzo@uthscsa.edu

210-567-0056

Facility Contacts

Robert DeLorenzo, MD

Role: primary

delorenzo@uthscsa.edu

210-567-4292

Stephanie Martinez

Role: backup

martinezs13@uthscsa.edu

210 450-8566

Steven G Schauer, DO

Role: primary

steven.g.schauer.mil@mail.mil

Other Identifiers

W81XWH-18-2-0074

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HSC20180520H

Identifier Type: -

Identifier Source: org_study_id