The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
39
Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
Fractures will be irrigated with sterile normal saline prior to closure.
All arms with receive standard parenteral (IV) prophylactic antibiotic.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Participants With Surgical Site Infection (SSI)
Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Time frame: 8 weeks
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