A Prospective Randomized Trial to Assess Oral Versus Intravenous Antibiotics for the Treatment of Postoperative Wound Infection After Extremity Fractures (POvIV Study).
Patients surgically treated for infection after extremity fractures are typically discharged with a 6- to 12-week antibiotic regimen. Intravenous (IV) antibiotics are associated with significant cost and potential complications of deep vein thrombosis, line clotting, and sepsis. Many of the pathogens that cause musculoskeletal infection have both oral (PO) and IV antibiotic options with adequate bioavailability and antibacterial effect, yet IV antibiotics remain the standard of care absent evidence that PO options are clinically as efficacious. The POvIV study is a prospective, multicenter, randomized trial to compare PO with IV antibiotic therapy in patients with postoperative wound infections after extremity fractures. Patients between the ages of 18 and 84 who have a culture-positive surgical site infection after internal fixation for fracture repair or arthrodesis are approached for this study, and if they provide consent, are randomly assigned to receive either PO or IV antibiotics. Antibiotic selection is based on culture and sensitivity results. Randomization determines the route of administration. Patients are followed for 1 year after study enrollment. This study will be the largest prospective randomized trial to evaluate the safety and effectiveness of PO antibiotic use for treatment of postoperative wound infections. Results will inform clinician decisions on antibiotic delivery in patients with postoperative wound infections.
*Department of Orthopaedic Surgery and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN; †Hennepin County Medical Center, Minneapolis, MN; ‡Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD; §Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; ‖Department of Orthopaedic Surgery, UCSF/SFGH Orthopaedic Trauma Institute, University of California, San Francisco, San Francisco, CA; ¶Boston University Medical Center, Boston, MA; **U.S. Army, Uniformed Services University of the Health Sciences, San Antonio Military Medical Center, Infectious Disease Service, San Antonio, TX; ††The CORE Institute, Banner University Medical Center, University of Arizona Medical College, Phoenix, AZ; and ‡‡Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
William T
WT
Obremskey
Andrew H
AH
Schmidt
Robert V
RV
OʼToole
Jennifer
J
DeSanto
Saam
S
Morshed
Paul
P
Tornetta
Clinton K
CK
Murray
Clifford B
CB
Jones
Daniel O
DO
Scharfstein
Tara J
TJ
Taylor
Anthony R
AR
Carlini
Renan C
RC
Castillo
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods / Q000706:statistics & numerical data*; D015984:Causality; D015897:Comorbidity; D005121:Extremities / Q000293:injuries / Q000601:surgery; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology* / Q000601:surgery*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000453:epidemiology* / Q000517:prevention & control*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D000900:Anti-Bacterial Agents