Placement of Antibiotic Powder in Wounds During the Emergency Room

ConditionOpen Fracture
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vancomycin

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators

The University of Texas Health Science Center at San Antonio

Lead sponsor

United States Army Institute of Surgical Research

Collaborator

San Antonio Military Medical Center

Collaborator