Placement of Antibiotic Powder in Wounds During the Emergency Room

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Brooke Army Medical Center; San Antonio Military Medical Center; United States Army Institute of Surgical Research
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Vancomycin

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.