Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial

Robert V. O'Toole*, Manjari Joshi, Anthony R. Carlini, Clinton K. Murray, Lauren E. Allen, Yanjie Huang, Daniel O. Scharfstein, Nathan N. O'Hara, Joshua L. Gary, Michael J. Bosse, Renan C. Castillo, Julius A. Bishop, Michael J. Weaver, Reza Firoozabadi, Joseph R. Hsu, Madhav A. Karunakar, Rachel B. Seymour, Stephen H. Sims, Christine Churchill, Michael L. BrennanGabriela Gonzales, Rachel M. Reilly, Robert D. Zura, Cameron R. Howes, Hassan R. Mir, Emily A. Wagstrom, Jerald Westberg, Greg E. Gaski, Laurence B. Kempton, Roman M. Natoli, Anthony T. Sorkin, Walter W. Virkus, Lauren C. Hill, Robert A. Hymes, Michael Holzman, A. Stephen Malekzadeh, Jeff E. Schulman, Lolita Ramsey, Jaslynn A.N. Cuff, Sharon Haaser, Greg M. Osgood, Babar Shafiq, Vaishali Laljani, Olivia C. Lee, Peter C. Krause, Cara J. Rowe, Colette L. Hilliard, Massimo Max Morandi, Angela Mullins, Timothy S. Achor, Andrew M. Choo, John W. Munz, Sterling J. Boutte, Heather A. Vallier, Mary A. Breslin, H. Michael Frisch, Adam M. Kaufman, Thomas M. Large, C. Michael Lecroy, Christina Riggsbee, Christopher S. Smith, Colin V. Crickard, Laura S. Phieffer, Elizabeth Sheridan, Clifford B. Jones, Debra L. Sietsema, J. Spence Reid, Kathy Ringenbach, Roman Hayda, Andrew R. Evans, M. J. Crisco, Jessica C. Rivera, Patrick M. Osborn, Joseph Kimmel, Stanislaw P. Stawicki, Chinenye O. Nwachuku, Thomas R. Wojda, Saqib Rehman, Joanne M. Donnelly, Cyrus Caroom, Mark D. Jenkins, Christina L. Boulton, Timothy G. Costales, Christopher T. Lebrun, Theodore T. Manson, Daniel C. Mascarenhas, Jason W. Nascone, Andrew N. Pollak, Marcus F. Sciadini, Gerard P. Slobogean, Peter Z. Berger, Daniel W. Connelly, Yasmin Degani, Andrea L. Howe, Dimitrius P. Marinos, Ryan N. Montalvo, G. Bradley Reahl, Carrie D. Schoonover, Lisa K. Schroder, Sandy Vang, Patrick F. Bergin, Matt L. Graves, George V. Russell, Clay A. Spitler, Josie M. Hydrick, David Teague, William Ertl, Lindsay E. Hickerson, Gele B. Moloney, John C. Weinlein, Boris A. Zelle, Animesh Agarwal, Ravi A. Karia, Ashoke K. Sathy, Brigham Au, Medardo Maroto, Drew Sanders, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, David B. Weiss, Seth R. Yarboro, Eric D. McVey, Veronica Lester-Ballard, David Goodspeed, Gerald J. Lang, Paul S. Whiting, Alexander B. Siy, William T. Obremskey, A. Alex Jahangir, Basem Attum, Eduardo J. Burgos, Cesar S. Molina, Andres Rodriguez-Buitrago, Vamshi Gajari, Karen M. Trochez, Jason J. Halvorson, Anna N. Miller, James Brett Goodman, Martha B. Holden, Christopher M. McAndrew, Michael J. Gardner, William M. Ricci, Amanda Spraggs-Hughes, Susan C. Collins, Tara J. Taylor, Mary Zadnik

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

68 Scopus citations


Importance: Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist. Objective: To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections. Design, Setting, and Participants: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. Interventions: A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder. Main Outcomes and Measures: The primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence. Results: The analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P =.06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P =.02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P =.78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections. Conclusions and Relevance: Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

Original languageEnglish
JournalJAMA Surgery
Issue number5
StatePublished - May 2021
Externally publishedYes


Dive into the research topics of 'Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial'. Together they form a unique fingerprint.

Cite this