Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures

Robert V. O’Toole(University of Maryland, Baltimore), Manjari Joshi(University of Maryland, Baltimore), Anthony R. Carlini(Johns Hopkins University), Clinton K. Murray(Brooke Army Medical Center), Lauren Allen(Johns Hopkins University), Yanjie Huang(Johns Hopkins University), Daniel O. Scharfstein(Johns Hopkins University), Nathan N. O’Hara(University of Maryland, Baltimore), Joshua L. Gary(The University of Texas Health Science Center at Houston), Michael J. Bosse(Carolinas Medical Center), Renan C. Castillo(Johns Hopkins University), Julius A. Bishop(Stanford University), Michael J. Weaver(Brigham and Women's Hospital), Reza Firoozabadi(University of Washington), Joseph R. Hsu(Carolinas Medical Center), Madhav A. Karunakar(Carolinas Medical Center), Rachel B. Seymour(Carolinas Medical Center), Stephen H. Sims(Carolinas Medical Center), Christine Churchill(Carolinas Medical Center), Michael Brennan(Baylor Medical Center at Garland), Gabriela Gonzales(Baylor Medical Center at Garland), Rachel M. Reilly(Duke University Hospital), Robert Zura(Duke University Hospital), Cameron Howes(Duke University Hospital), Hassan R. Mir(Tampa General Hospital), Emily Wagstrom(Hennepin County Medical Center), Jerald R. Westberg(Hennepin County Medical Center), Greg E. Gaski(Methodist Hospital), Laurence B. Kempton(Methodist Hospital), Roman M. Natoli(Methodist Hospital), Anthony T. Sorkin(Methodist Hospital), Walter W. Virkus(Methodist Hospital), Lauren C. Hill(Methodist Hospital), Robert A. Hymes(Inova Fairfax Hospital), Michael A. Holzman(Inova Fairfax Hospital), Arjan Malekzadeh(Inova Fairfax Hospital), Jeff E. Schulman(Inova Fairfax Hospital), Lolita Ramsey(Inova Fairfax Hospital), Jaslynn Cuff(Inova Fairfax Hospital), Sharon Haaser(Inova Fairfax Hospital), Greg Osgood(Johns Hopkins Hospital), Babar Shafiq(Johns Hopkins Hospital), Vaishali Laljani(Johns Hopkins Hospital), Olivia Lee(Louisiana State University Health Sciences Center New Orleans), Peter C. Krause(Louisiana State University Health Sciences Center New Orleans), Cara J. Rowe(Louisiana State University Health Sciences Center New Orleans), Colette L. Hilliard(Louisiana State University Health Sciences Center New Orleans), Massimo Morandi(Louisiana State University Health Sciences Center Shreveport), Angela Mullins(Louisiana State University Health Sciences Center Shreveport), Timothy S. Achor(The University of Texas Health Science Center at Houston), Andrew M. Choo(The University of Texas Health Science Center at Houston), John W. Munz(The University of Texas Health Science Center at Houston), Sterling Boutte(The University of Texas Health Science Center at Houston), Heather A. Vallier(MetroHealth), Mary A. Breslin(MetroHealth), H Frisch(Mission Health), Adam M. Kaufman(Mission Health), Thomas M. Large(Mission Health), C. Michael LeCroy(Mission Health), Christina Riggsbee(Mission Health), Christopher Smith(Naval Medical Center Portsmouth), Colin V. Crickard(Naval Medical Center Portsmouth), Laura S. Phieffer(The Ohio State University Wexner Medical Center), Elizabeth Sheridan(The Ohio State University Wexner Medical Center), Clifford B. Jones(Corewell Health Blodgett Hospital), Debra L. Sietsema(Corewell Health Blodgett Hospital), J. Spence Reid(Penn State Milton S. Hershey Medical Center), Kathy Ringenbach(Penn State Milton S. Hershey Medical Center), Roman A. Hayda(Brown University), Andrew R. Evans(Brown University), M.J. Crisco(Brown University), Jessica C. Rivera(Brooke Army Medical Center), Patrick M. Osborn(Brooke Army Medical Center), Joseph Kimmel(Brooke Army Medical Center), Stanislaw P. Stawicki(St. Luke's University Health Network), Chinenye O. Nwachuku(St. Luke's University Health Network), Thomas R. Wojda(St. Luke's University Health Network), Saqib Rehman(Temple University), Joanne Donnelly(Temple University), Cyrus Caroom(Texas Tech University), Mark Jenkins(Texas Tech University), Christina Boulton(University of Maryland, Baltimore), Timothy Costales(University of Maryland, Baltimore), Christopher Lebrun(University of Maryland, Baltimore), Theodore T. Manson(University of Maryland, Baltimore), Daniel Mascarenhas(University of Maryland, Baltimore), Jason W. Nascone(University of Maryland, Baltimore), Andrew N. Pollak(University of Maryland, Baltimore), Marcus F. Sciadini(University of Maryland, Baltimore), Gerard P. Slobogean(University of Maryland, Baltimore), Peter Z. Berger(University of Maryland, Baltimore), Daniel Connelly(University of Maryland, Baltimore), Yasmin Degani(University of Maryland, Baltimore), Andrea Howe(University of Maryland, Baltimore), Dimitrius Marinos(University of Maryland, Baltimore), Ryan N. Montalvo(University of Maryland, Baltimore), G. Bradley Reahl(University of Maryland, Baltimore), Carrie Schoonover(University of Maryland, Baltimore), Lisa K. Schroder(Regions Hospital), Sandy Vang(Regions Hospital), Patrick F. Bergin(University of Mississippi Medical Center), Matt L. Graves(University of Mississippi Medical Center), George V. Russell(University of Mississippi Medical Center), Clay A. Spitler(University of Mississippi Medical Center), Josie M. Hydrick(University of Mississippi Medical Center), David Teague(University of Oklahoma), William J. Ertl(University of Oklahoma), Lindsay E. Hickerson(University of Oklahoma), Gele B. Moloney(University of Pittsburgh Medical Center), John C. Weinlein(Campbell Clinic), Boris A. Zelle(The University of Texas at San Antonio Health Science Center), Animesh Agarwal(The University of Texas at San Antonio Health Science Center), Ravi A. Karia(The University of Texas at San Antonio Health Science Center), Ashoke Sathy(The University of Texas Southwestern Medical Center), Brigham K. Au(The University of Texas Southwestern Medical Center), Medardo Maroto(The University of Texas Southwestern Medical Center), Drew Sanders(The University of Texas Southwestern Medical Center), Thomas F. Higgins(University of Utah), Justin M. Haller(University of Utah), David L. Rothberg(University of Utah), David B. Weiss(University of Virginia), Seth R. Yarboro(University of Virginia), Eric D. McVey(University of Virginia), Veronica Lester-Ballard(University of Virginia), David C. Goodspeed(University of Wisconsin–Madison), Gerald J. Lang(University of Wisconsin–Madison), Paul S. Whiting(University of Wisconsin–Madison), Alexander B. Siy(University of Wisconsin–Madison), William T. Obremskey(Vanderbilt University Medical Center), A. Alex Jahangir(Vanderbilt University Medical Center), Basem Attum(Vanderbilt University Medical Center), Eduardo J. Burgos(Vanderbilt University Medical Center), Cesar S. Molina(Vanderbilt University Medical Center), Andres Rodriguez-Buitrago(Vanderbilt University Medical Center), Vamshi Gajari(Vanderbilt University Medical Center), Karen Trochez(Vanderbilt University Medical Center), Jason J. Halvorson(Atrium Health Wake Forest Baptist), Anna N. Miller(Atrium Health Wake Forest Baptist), J. Brett Goodman(Atrium Health Wake Forest Baptist), Martha B. Holden(Atrium Health Wake Forest Baptist), Christopher M. McAndrew(Barnes-Jewish Hospital), Michael J. Gardner(Barnes-Jewish Hospital), William M. Ricci(Barnes-Jewish Hospital), Amanda Spraggs-Hughes(Barnes-Jewish Hospital), Susan Collins(Johns Hopkins University), Tara Taylor(Johns Hopkins University), Mary Zadnik(Johns Hopkins University)
JAMA Surgery
March 24, 2021
10.1001/jamasurg.2020.7259
Cited by 118Open Access
Full Text

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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