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, O'Toole RV, Joshi M, et al. Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial. JAMA Surg. 2021;156(5):e207259doi: 10.1001/jamasurg.2020.7259.
, O'Toole, R. V., Joshi, M., Carlini, A. R., Murray, C. K., Allen, L. E., Huang, Y., Scharfstein, D. O., O'Hara, N. N., Gary, J. L., Bosse, M. J., Castillo, R. C., Bishop, J. A., Weaver, M. J., Firoozabadi, R., Hsu, J. R., Karunakar, M. A., Seymour, R. B., Sims, S. H., Churchill, C., Brennan, M. L., Gonzales, G., Reilly, R. M., Zura, R. D., Howes, C. R., Mir, H. R., Wagstrom, E. A., Westberg, J., Gaski, G. E., Kempton, L. B., Natoli, R. M., Sorkin, A. T., Virkus, W. W., Hill, L. C., Hymes, R. A., Holzman, M., Malekzadeh, A. S., Schulman, J. E., Ramsey, L., Cuff, J. A. N., Haaser, S., Osgood, G. M., Shafiq, B., Laljani, V., Lee, O. C., Krause, P. C., Rowe, C. J., Hilliard, C. L., Morandi, M. M., Mullins, A., Achor, T. S., Choo, A. M., Munz, J. W., Boutte, S. J., Vallier, H. A., Breslin, M. A., Frisch, H. M., Kaufman, A. M., Large, T. M., LeCroy, C. M., Riggsbee, C., Smith, C. S., Crickard, C. V., Phieffer, L. S., Sheridan, E., Jones, C. B., Sietsema, D. L., Reid, J. S., Ringenbach, K., Hayda, R., Evans, A. R., Crisco, M. J., Rivera, J. C., Osborn, P. M., Kimmel, J., Stawicki, S. P., Nwachuku, C. O., Wojda, T. R., Rehman, S., Donnelly, J. M., Caroom, C., Jenkins, M. D., Boulton, C. L., Costales, T. G., LeBrun, C. T., Manson, T. T., Mascarenhas, D. C., Nascone, J. W., Pollak, A. N., Sciadini, M. F., Slobogean, G. P., Berger, P. Z., Connelly, D. W., Degani, Y., Howe, A. L., Marinos, D. P., Montalvo, R. N., Reahl, G. B., Schoonover, C. D., Schroder, L. K., Vang, S., Bergin, P. F., Graves, M. L., Russell, G. V., Spitler, C. A., Hydrick, J. M., Teague, D., Ertl, W., Hickerson, L. E., Moloney, G. B., Weinlein, J. C., Zelle, B. A., Agarwal, A., Karia, R. A., Sathy, A. K., Au, B., Maroto, M., Sanders, D., Higgins, T. F., Haller, J. M., Rothberg, D. L., Weiss, D. B., Yarboro, S. R., McVey, E. D., Lester-Ballard, V., Goodspeed, D., Lang, G. J., Whiting, P. S., Siy, A. B., Obremskey, W. T., Jahangir, A. A., Attum, B., Burgos, E. J., Molina, C. S., Rodriguez-Buitrago, A., Gajari, V., Trochez, K. M., Halvorson, J. J., Miller, A. N., Goodman, J. B., Holden, M. B., McAndrew, C. M., Gardner, M. J., Ricci, W. M., Spraggs-Hughes, A., Collins, S. C., Taylor, T. J., & Zadnik, M. (2021). Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial. JAMA surgery, 156(5), e207259. https://doi.org/10.1001/jamasurg.2020.7259
, et al. "Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial." JAMA surgery vol. 156,5 (2021): e207259. doi: https://doi.org/10.1001/jamasurg.2020.7259
, O'Toole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Huang Y, Scharfstein DO, O'Hara NN, Gary JL, Bosse MJ, Castillo RC, Bishop JA, Weaver MJ, Firoozabadi R, Hsu JR, Karunakar MA, Seymour RB, Sims SH, Churchill C, Brennan ML, Gonzales G, Reilly RM, Zura RD, Howes CR, Mir HR, Wagstrom EA, Westberg J, Gaski GE, Kempton LB, Natoli RM, Sorkin AT, Virkus WW, Hill LC, Hymes RA, Holzman M, Malekzadeh AS, Schulman JE, Ramsey L, Cuff JAN, Haaser S, Osgood GM, Shafiq B, Laljani V, Lee OC, Krause PC, Rowe CJ, Hilliard CL, Morandi MM, Mullins A, Achor TS, Choo AM, Munz JW, Boutte SJ, Vallier HA, Breslin MA, Frisch HM, Kaufman AM, Large TM, LeCroy CM, Riggsbee C, Smith CS, Crickard CV, Phieffer LS, Sheridan E, Jones CB, Sietsema DL, Reid JS, Ringenbach K, Hayda R, Evans AR, Crisco MJ, Rivera JC, Osborn PM, Kimmel J, Stawicki SP, Nwachuku CO, Wojda TR, Rehman S, Donnelly JM, Caroom C, Jenkins MD, Boulton CL, Costales TG, LeBrun CT, Manson TT, Mascarenhas DC, Nascone JW, Pollak AN, Sciadini MF, Slobogean GP, Berger PZ, Connelly DW, Degani Y, Howe AL, Marinos DP, Montalvo RN, Reahl GB, Schoonover CD, Schroder LK, Vang S, Bergin PF, Graves ML, Russell GV, Spitler CA, Hydrick JM, Teague D, Ertl W, Hickerson LE, Moloney GB, Weinlein JC, Zelle BA, Agarwal A, Karia RA, Sathy AK, Au B, Maroto M, Sanders D, Higgins TF, Haller JM, Rothberg DL, Weiss DB, Yarboro SR, McVey ED, Lester-Ballard V, Goodspeed D, Lang GJ, Whiting PS, Siy AB, Obremskey WT, Jahangir AA, Attum B, Burgos EJ, Molina CS, Rodriguez-Buitrago A, Gajari V, Trochez KM, Halvorson JJ, Miller AN, Goodman JB, Holden MB, McAndrew CM, Gardner MJ, Ricci WM, Spraggs-Hughes A, Collins SC, Taylor TJ, Zadnik M. Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial. JAMA Surg. 2021 May 01;156(5):e207259. doi: 10.1001/jamasurg.2020.7259. Epub 2021 May 12. PMID: 33760010.
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JAMA Surg. 2021 May 01;156(5):e207259. doi: 10.1001/jamasurg.2020.7259. Epub 2021 May 12.

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

JAMA surgery

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 Brennan, Gabriela 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

Affiliations

  1. Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore.
  2. Department of Infectious Diseases, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore.
  3. Major Extremity Trauma Research Consortium Coordinating Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
  4. Department of Medicine, San Antonio Military Medical Center, San Antonio, Texas.
  5. Department of Orthopedic Surgery, McGovern Medical School, University of Texas Health Science Center at Houston, Houston.
  6. Atrium Health Musculoskeletal Institute, Carolinas Medical Center, Charlotte, North Carolina.
  7. Department of Orthopaedic Surgery, Stanford University, Palo Alto, California.
  8. Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
  9. Department of Orthopaedics and Sports Medicine, Harborview Medical Center/University of Washington, Seattle.
  10. Department of Orthopaedic Surgery, Baylor Scott and White Memorial Center, Temple, Texas.
  11. Department of Orthopaedic Surgery, Duke University, Durham, North Carolina.
  12. Florida Orthopaedic Institute/Tampa General Hospital, Tampa.
  13. Department of Orthopaedic Surgery, Hennepin County Medical Center, Minneapolis, Minnesota.
  14. Department of Orthopaedic Surgery, Indiana University Methodist Hospital, Indianapolis.
  15. Department of Orthopedic Surgery, Inova Fairfax Medical Campus, Fairfax, Virginia.
  16. Department of Orthopaedic Surgery, Johns Hopkins Hospital, Baltimore, Maryland.
  17. Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center, New Orleans.
  18. Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center, Shreveport.
  19. Department of Orthopaedics, MetroHealth, Cleveland, Ohio.
  20. Orthopaedic Trauma Service, Mission Health, Asheville, North Carolina.
  21. Research Institute, Mission Health, Asheville, North Carolina.
  22. Department of Orthopaedic Surgery, Naval Medical Center Portsmouth, Portsmouth, Virginia.
  23. Department of Orthopaedics, Ohio State University, Wexner Medical Center, Columbus.
  24. Spectrum Health, Grand Rapids, Michigan.
  25. Department of Orthopaedics and Rehabilitation, Penn State Health, Hershey, Pennsylvania.
  26. Department of Orthopedic Surgery, Brown University/Rhode Island Hospital, Providence.
  27. Department of Orthopaedic Surgery, San Antonio Military Medical Center, San Antonio, Texas.
  28. Department of Research and Innovation, St. Luke's University Health Network, Bethlehem, Pennsylvania.
  29. Department of Orthopedic Surgery, St. Luke's University Health Network, Bethlehem, Pennsylvania.
  30. Department of Family Medicine, St. Luke's University Health Network, Bethlehem, Pennsylvania.
  31. Department of Orthopaedic Surgery and Sports Medicine, Temple University, Philadelphia, Pennsylvania.
  32. Department of Orthopaedics, Texas Tech University Health Sciences Center, Lubbock.
  33. Department of Orthopaedic Surgery, University of Minnesota-Regions Hospital, St Paul.
  34. Department of Orthopaedic Surgery, University of Mississippi Medical Center, Jackson.
  35. Department of Orthopedic Surgery and Rehabilitation, University of Oklahoma, Oklahoma City.
  36. Department of Orthopaedic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
  37. Department of Orthopaedic Surgery, University of Tennessee-Campbell Clinic, Memphis.
  38. Department of Orthopaedics, University of Texas Health at San Antonio, San Antonio.
  39. Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas.
  40. Department of Orthopaedics, University of Utah, Salt Lake City.
  41. Department of Orthopaedic Surgery, University of Virginia School of Medicine, Charlottesville.
  42. Department of Orthopedics and Rehabilitation, University of Wisconsin School of Medicine and Public Health, Madison.
  43. Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
  44. Department of Orthopaedic Surgery and Rehabilitation, Wake Forest Baptist University Medical Center, Winston-Salem, North Carolina.
  45. Department of Orthopedic Surgery, Washington University in St Louis/Barnes Jewish Hospital, St Louis, Missouri.

PMID: 33760010 DOI: 10.1001/jamasurg.2020.7259

Abstract

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.

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