Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial
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, SETTIN...
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| Veröffentlicht in: | Archives of surgery (Chicago. 1960) 2021-05, Vol.156 (5), p.e207259-e207259 |
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| creator | O’Toole, Robert V Joshi, Manjari Allen, Lauren E Huang, Yanjie Gary, Joshua L Castillo, Renan C Bishop, Julius A Firoozabadi, Reza Karunakar, Madhav A Seymour, Rachel B Sims, Stephen H Churchill, Christine Brennan, Michael L Reilly, Rachel M Howes, Cameron R Mir, Hassan R Kempton, Laurence B Natoli, Roman M Virkus, Walter W Hymes, Robert A Holzman, Michael Malekzadeh, A. Stephen Schulman, Jeff E Haaser, Sharon Osgood, Greg M Lee, Olivia C Krause, Peter C Rowe, Cara J Hilliard, Colette L Morandi, Massimo Max Mullins, Angela Achor, Timothy S Choo, Andrew M Boutte, Sterling J Vallier, Heather A Breslin, Mary A Frisch, H. Michael Kaufman, Adam M Large, Thomas M LeCroy, C. Michael Phieffer, Laura S Sheridan, Elizabeth Sietsema, Debra L Reid, J. Spence Hayda, Roman Evans, Andrew R Rivera, Jessica C Osborn, Patrick M Kimmel, Joseph Stawicki, Stanislaw P Nwachuku, Chinenye O Wojda, Thomas R Rehman, Saqib Donnelly, Joanne M Caroom, Cyrus Boulton, Christina L Costales, Timothy G LeBrun, Christopher T Mascarenhas, Daniel C Berger, Peter Z Degani, Yasmin Howe, Andrea L Marinos, Dimitrius P Montalvo, Ryan N Reahl, G. Bradley Schroder, Lisa K Vang, Sandy Bergin, Patrick F Russell, George V Spitler, Clay A Teague, David Ertl, William Hickerson, Lindsay E Moloney, Gele B Weinlein, John C Agarwal, Animesh Karia, Ravi A Sathy, Ashoke K Maroto, Medardo Sanders, Drew Higgins, Thomas F Rothberg, David L Lester-Ballard, Veronica Whiting, Paul S Siy, Alexander B Obremskey, William T Jahangir, A. Alex Molina, Cesar S Rodriguez-Buitrago, Andres Gajari, Vamshi Trochez, Karen M Halvorson, Jason J Miller, Anna N Goodman, James Brett McAndrew, Christopher M Ricci, William M Spraggs-Hughes, Amanda Collins, Susan C Taylor, Tara J Zadnik, Mary |
| description | 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 |
| doi_str_mv | 10.1001/jamasurg.2020.7259 |
| format | Article |
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Stephen ; Schulman, Jeff E ; Haaser, Sharon ; Osgood, Greg M ; Lee, Olivia C ; Krause, Peter C ; Rowe, Cara J ; Hilliard, Colette L ; Morandi, Massimo Max ; Mullins, Angela ; Achor, Timothy S ; Choo, Andrew M ; Boutte, Sterling J ; Vallier, Heather A ; Breslin, Mary A ; Frisch, H. Michael ; Kaufman, Adam M ; Large, Thomas M ; LeCroy, C. Michael ; Phieffer, Laura S ; Sheridan, Elizabeth ; Sietsema, Debra L ; Reid, J. Spence ; Hayda, Roman ; Evans, Andrew R ; Rivera, Jessica C ; Osborn, Patrick M ; Kimmel, Joseph ; Stawicki, Stanislaw P ; Nwachuku, Chinenye O ; Wojda, Thomas R ; Rehman, Saqib ; Donnelly, Joanne M ; Caroom, Cyrus ; Boulton, Christina L ; Costales, Timothy G ; LeBrun, Christopher T ; Mascarenhas, Daniel C ; Berger, Peter Z ; Degani, Yasmin ; Howe, Andrea L ; Marinos, Dimitrius P ; Montalvo, Ryan N ; Reahl, G. Bradley ; Schroder, Lisa K ; Vang, Sandy ; Bergin, Patrick F ; Russell, George V ; Spitler, Clay A ; Teague, David ; Ertl, William ; Hickerson, Lindsay E ; Moloney, Gele B ; Weinlein, John C ; Agarwal, Animesh ; Karia, Ravi A ; Sathy, Ashoke K ; Maroto, Medardo ; Sanders, Drew ; Higgins, Thomas F ; Rothberg, David L ; Lester-Ballard, Veronica ; Whiting, Paul S ; Siy, Alexander B ; Obremskey, William T ; Jahangir, A. Alex ; Molina, Cesar S ; Rodriguez-Buitrago, Andres ; Gajari, Vamshi ; Trochez, Karen M ; Halvorson, Jason J ; Miller, Anna N ; Goodman, James Brett ; McAndrew, Christopher M ; Ricci, William M ; Spraggs-Hughes, Amanda ; Collins, Susan C ; Taylor, Tara J ; Zadnik, Mary</creator><creatorcontrib>O’Toole, Robert V ; Joshi, Manjari ; Allen, Lauren E ; Huang, Yanjie ; Gary, Joshua L ; Castillo, Renan C ; Bishop, Julius A ; Firoozabadi, Reza ; Karunakar, Madhav A ; Seymour, Rachel B ; Sims, Stephen H ; Churchill, Christine ; Brennan, Michael L ; Reilly, Rachel M ; Howes, Cameron R ; Mir, Hassan R ; Kempton, Laurence B ; Natoli, Roman M ; Virkus, Walter W ; Hymes, Robert A ; Holzman, Michael ; Malekzadeh, A. Stephen ; Schulman, Jeff E ; Haaser, Sharon ; Osgood, Greg M ; Lee, Olivia C ; Krause, Peter C ; Rowe, Cara J ; Hilliard, Colette L ; Morandi, Massimo Max ; Mullins, Angela ; Achor, Timothy S ; Choo, Andrew M ; Boutte, Sterling J ; Vallier, Heather A ; Breslin, Mary A ; Frisch, H. Michael ; Kaufman, Adam M ; Large, Thomas M ; LeCroy, C. Michael ; Phieffer, Laura S ; Sheridan, Elizabeth ; Sietsema, Debra L ; Reid, J. Spence ; Hayda, Roman ; Evans, Andrew R ; Rivera, Jessica C ; Osborn, Patrick M ; Kimmel, Joseph ; Stawicki, Stanislaw P ; Nwachuku, Chinenye O ; Wojda, Thomas R ; Rehman, Saqib ; Donnelly, Joanne M ; Caroom, Cyrus ; Boulton, Christina L ; Costales, Timothy G ; LeBrun, Christopher T ; Mascarenhas, Daniel C ; Berger, Peter Z ; Degani, Yasmin ; Howe, Andrea L ; Marinos, Dimitrius P ; Montalvo, Ryan N ; Reahl, G. Bradley ; Schroder, Lisa K ; Vang, Sandy ; Bergin, Patrick F ; Russell, George V ; Spitler, Clay A ; Teague, David ; Ertl, William ; Hickerson, Lindsay E ; Moloney, Gele B ; Weinlein, John C ; Agarwal, Animesh ; Karia, Ravi A ; Sathy, Ashoke K ; Maroto, Medardo ; Sanders, Drew ; Higgins, Thomas F ; Rothberg, David L ; Lester-Ballard, Veronica ; Whiting, Paul S ; Siy, Alexander B ; Obremskey, William T ; Jahangir, A. Alex ; Molina, Cesar S ; Rodriguez-Buitrago, Andres ; Gajari, Vamshi ; Trochez, Karen M ; Halvorson, Jason J ; Miller, Anna N ; Goodman, James Brett ; McAndrew, Christopher M ; Ricci, William M ; Spraggs-Hughes, Amanda ; Collins, Susan C ; Taylor, Tara J ; Zadnik, Mary ; Major Extremity Trauma Research Consortium (METRC) ; The Major Extremity Trauma Research Consortium (METRC)</creatorcontrib><description>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</description><identifier>ISSN: 2168-6254</identifier><identifier>EISSN: 2168-6262</identifier><identifier>DOI: 10.1001/jamasurg.2020.7259</identifier><identifier>PMID: 33760010</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adult ; Anti-Bacterial Agents - administration & dosage ; Anti-Bacterial Agents - therapeutic use ; Antibiotics ; Clinical trials ; Double-Blind Method ; Female ; Fracture Fixation, Internal - adverse effects ; Fractures, Ununited - etiology ; Gram-Negative Bacterial Infections - prevention & control ; Gram-Positive Bacterial Infections - prevention & control ; Humans ; Intra-Articular Fractures - surgery ; Male ; Middle Aged ; Powders ; Probability ; Prospective Studies ; Risk assessment ; Risk factors ; Studies ; Surgery ; Surgical outcomes ; Surgical Wound Dehiscence - etiology ; Surgical Wound Infection - etiology ; Surgical Wound Infection - prevention & control ; Tibial Fractures - surgery ; Time Factors ; Vancomycin - administration & dosage ; Vancomycin - therapeutic use</subject><ispartof>Archives of surgery (Chicago. 1960), 2021-05, Vol.156 (5), p.e207259-e207259</ispartof><rights>Copyright American Medical Association May 2021</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a301t-bff99ce8697d5ae58e0df6e2fcec35bc6cc892ab229874daba232662cef36dce3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jamasurgery/articlepdf/10.1001/jamasurg.2020.7259$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jamasurgery/fullarticle/10.1001/jamasurg.2020.7259$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76458,76461</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33760010$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>O’Toole, Robert V</creatorcontrib><creatorcontrib>Joshi, Manjari</creatorcontrib><creatorcontrib>Allen, Lauren E</creatorcontrib><creatorcontrib>Huang, Yanjie</creatorcontrib><creatorcontrib>Gary, Joshua L</creatorcontrib><creatorcontrib>Castillo, Renan C</creatorcontrib><creatorcontrib>Bishop, Julius A</creatorcontrib><creatorcontrib>Firoozabadi, Reza</creatorcontrib><creatorcontrib>Karunakar, Madhav A</creatorcontrib><creatorcontrib>Seymour, Rachel B</creatorcontrib><creatorcontrib>Sims, Stephen H</creatorcontrib><creatorcontrib>Churchill, Christine</creatorcontrib><creatorcontrib>Brennan, Michael L</creatorcontrib><creatorcontrib>Reilly, Rachel M</creatorcontrib><creatorcontrib>Howes, Cameron R</creatorcontrib><creatorcontrib>Mir, Hassan R</creatorcontrib><creatorcontrib>Kempton, Laurence B</creatorcontrib><creatorcontrib>Natoli, Roman M</creatorcontrib><creatorcontrib>Virkus, Walter W</creatorcontrib><creatorcontrib>Hymes, Robert A</creatorcontrib><creatorcontrib>Holzman, Michael</creatorcontrib><creatorcontrib>Malekzadeh, A. Stephen</creatorcontrib><creatorcontrib>Schulman, Jeff E</creatorcontrib><creatorcontrib>Haaser, Sharon</creatorcontrib><creatorcontrib>Osgood, Greg M</creatorcontrib><creatorcontrib>Lee, Olivia C</creatorcontrib><creatorcontrib>Krause, Peter C</creatorcontrib><creatorcontrib>Rowe, Cara J</creatorcontrib><creatorcontrib>Hilliard, Colette L</creatorcontrib><creatorcontrib>Morandi, Massimo Max</creatorcontrib><creatorcontrib>Mullins, Angela</creatorcontrib><creatorcontrib>Achor, Timothy S</creatorcontrib><creatorcontrib>Choo, Andrew M</creatorcontrib><creatorcontrib>Boutte, Sterling J</creatorcontrib><creatorcontrib>Vallier, Heather A</creatorcontrib><creatorcontrib>Breslin, Mary A</creatorcontrib><creatorcontrib>Frisch, H. Michael</creatorcontrib><creatorcontrib>Kaufman, Adam M</creatorcontrib><creatorcontrib>Large, Thomas M</creatorcontrib><creatorcontrib>LeCroy, C. Michael</creatorcontrib><creatorcontrib>Phieffer, Laura S</creatorcontrib><creatorcontrib>Sheridan, Elizabeth</creatorcontrib><creatorcontrib>Sietsema, Debra L</creatorcontrib><creatorcontrib>Reid, J. Spence</creatorcontrib><creatorcontrib>Hayda, Roman</creatorcontrib><creatorcontrib>Evans, Andrew R</creatorcontrib><creatorcontrib>Rivera, Jessica C</creatorcontrib><creatorcontrib>Osborn, Patrick M</creatorcontrib><creatorcontrib>Kimmel, Joseph</creatorcontrib><creatorcontrib>Stawicki, Stanislaw P</creatorcontrib><creatorcontrib>Nwachuku, Chinenye O</creatorcontrib><creatorcontrib>Wojda, Thomas R</creatorcontrib><creatorcontrib>Rehman, Saqib</creatorcontrib><creatorcontrib>Donnelly, Joanne M</creatorcontrib><creatorcontrib>Caroom, Cyrus</creatorcontrib><creatorcontrib>Boulton, Christina L</creatorcontrib><creatorcontrib>Costales, Timothy G</creatorcontrib><creatorcontrib>LeBrun, Christopher T</creatorcontrib><creatorcontrib>Mascarenhas, Daniel C</creatorcontrib><creatorcontrib>Berger, Peter Z</creatorcontrib><creatorcontrib>Degani, Yasmin</creatorcontrib><creatorcontrib>Howe, Andrea L</creatorcontrib><creatorcontrib>Marinos, Dimitrius P</creatorcontrib><creatorcontrib>Montalvo, Ryan N</creatorcontrib><creatorcontrib>Reahl, G. Bradley</creatorcontrib><creatorcontrib>Schroder, Lisa K</creatorcontrib><creatorcontrib>Vang, Sandy</creatorcontrib><creatorcontrib>Bergin, Patrick F</creatorcontrib><creatorcontrib>Russell, George V</creatorcontrib><creatorcontrib>Spitler, Clay A</creatorcontrib><creatorcontrib>Teague, David</creatorcontrib><creatorcontrib>Ertl, William</creatorcontrib><creatorcontrib>Hickerson, Lindsay E</creatorcontrib><creatorcontrib>Moloney, Gele B</creatorcontrib><creatorcontrib>Weinlein, John C</creatorcontrib><creatorcontrib>Agarwal, Animesh</creatorcontrib><creatorcontrib>Karia, Ravi A</creatorcontrib><creatorcontrib>Sathy, Ashoke K</creatorcontrib><creatorcontrib>Maroto, Medardo</creatorcontrib><creatorcontrib>Sanders, Drew</creatorcontrib><creatorcontrib>Higgins, Thomas F</creatorcontrib><creatorcontrib>Rothberg, David L</creatorcontrib><creatorcontrib>Lester-Ballard, Veronica</creatorcontrib><creatorcontrib>Whiting, Paul S</creatorcontrib><creatorcontrib>Siy, Alexander B</creatorcontrib><creatorcontrib>Obremskey, William T</creatorcontrib><creatorcontrib>Jahangir, A. Alex</creatorcontrib><creatorcontrib>Molina, Cesar S</creatorcontrib><creatorcontrib>Rodriguez-Buitrago, Andres</creatorcontrib><creatorcontrib>Gajari, Vamshi</creatorcontrib><creatorcontrib>Trochez, Karen M</creatorcontrib><creatorcontrib>Halvorson, Jason J</creatorcontrib><creatorcontrib>Miller, Anna N</creatorcontrib><creatorcontrib>Goodman, James Brett</creatorcontrib><creatorcontrib>McAndrew, Christopher M</creatorcontrib><creatorcontrib>Ricci, William M</creatorcontrib><creatorcontrib>Spraggs-Hughes, Amanda</creatorcontrib><creatorcontrib>Collins, Susan C</creatorcontrib><creatorcontrib>Taylor, Tara J</creatorcontrib><creatorcontrib>Zadnik, Mary</creatorcontrib><creatorcontrib>Major Extremity Trauma Research Consortium (METRC)</creatorcontrib><creatorcontrib>The Major Extremity Trauma Research Consortium (METRC)</creatorcontrib><title>Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial</title><title>Archives of surgery (Chicago. 1960)</title><addtitle>JAMA Surg</addtitle><description>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</description><subject>Adult</subject><subject>Anti-Bacterial Agents - administration & dosage</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibiotics</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fracture Fixation, Internal - adverse effects</subject><subject>Fractures, Ununited - etiology</subject><subject>Gram-Negative Bacterial Infections - prevention & control</subject><subject>Gram-Positive Bacterial Infections - prevention & control</subject><subject>Humans</subject><subject>Intra-Articular Fractures - surgery</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Powders</subject><subject>Probability</subject><subject>Prospective Studies</subject><subject>Risk assessment</subject><subject>Risk factors</subject><subject>Studies</subject><subject>Surgery</subject><subject>Surgical outcomes</subject><subject>Surgical Wound Dehiscence - etiology</subject><subject>Surgical Wound Infection - etiology</subject><subject>Surgical Wound Infection - prevention & control</subject><subject>Tibial Fractures - surgery</subject><subject>Time Factors</subject><subject>Vancomycin - administration & dosage</subject><subject>Vancomycin - therapeutic use</subject><issn>2168-6254</issn><issn>2168-6262</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU1r3DAQhkVpaEKSP5BDEfTSizeytJKt3sKSLwgkhG2vZiyNUm1tayvZCZtfHy2b7CFz0YCe92XgIeSsZLOSsfJ8BT2kKT7NOONsVnGpv5AjXqq6UFzxr_tdzg_JaUorlqdmbC70N3IoRKVyCTsi46VzaEYaHL0dxggvYRos_QODCf3G-IE-hBeLkebtfo0RRv-M3YYuI8KIlt74p79F9OkfXfrWA72KYMYpYvpFL-gjDDb0_jVzi84P3kCXgx66E3LgoEt4-v4ek99Xl8vFTXF3f327uLgrQLByLFrntDZYK11ZCShrZNYp5M6gEbI1yphac2g513U1t9ACF1wpbtAJZQ2KY_Jz17uO4f-EaWx6nwx2HQwYptRwyeaV0lrLjP74hK7CFId8XaaEkkJLzjLFd5SJIaWIrllH30PcNCVrtlqaDy3NVkuz1ZJD39-rp7ZHu498SMjA2Q7I2f0vr_LoWrwBTESUKQ</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>O’Toole, Robert V</creator><creator>Joshi, Manjari</creator><creator>Allen, Lauren E</creator><creator>Huang, Yanjie</creator><creator>Gary, Joshua L</creator><creator>Castillo, Renan C</creator><creator>Bishop, Julius A</creator><creator>Firoozabadi, Reza</creator><creator>Karunakar, Madhav A</creator><creator>Seymour, Rachel B</creator><creator>Sims, Stephen H</creator><creator>Churchill, Christine</creator><creator>Brennan, Michael L</creator><creator>Reilly, Rachel M</creator><creator>Howes, Cameron R</creator><creator>Mir, Hassan R</creator><creator>Kempton, Laurence B</creator><creator>Natoli, Roman M</creator><creator>Virkus, Walter W</creator><creator>Hymes, Robert A</creator><creator>Holzman, Michael</creator><creator>Malekzadeh, A. 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Alex</creator><creator>Molina, Cesar S</creator><creator>Rodriguez-Buitrago, Andres</creator><creator>Gajari, Vamshi</creator><creator>Trochez, Karen M</creator><creator>Halvorson, Jason J</creator><creator>Miller, Anna N</creator><creator>Goodman, James Brett</creator><creator>McAndrew, Christopher M</creator><creator>Ricci, William M</creator><creator>Spraggs-Hughes, Amanda</creator><creator>Collins, Susan C</creator><creator>Taylor, Tara J</creator><creator>Zadnik, Mary</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>20210501</creationdate><title>Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial</title><author>O’Toole, Robert V ; Joshi, Manjari ; Allen, Lauren E ; Huang, Yanjie ; Gary, Joshua L ; Castillo, Renan C ; Bishop, Julius A ; Firoozabadi, Reza ; Karunakar, Madhav A ; Seymour, Rachel B ; Sims, Stephen H ; Churchill, Christine ; Brennan, Michael L ; Reilly, Rachel M ; Howes, Cameron R ; Mir, Hassan R ; Kempton, Laurence B ; Natoli, Roman M ; Virkus, Walter W ; Hymes, Robert A ; Holzman, Michael ; Malekzadeh, A. Stephen ; Schulman, Jeff E ; Haaser, Sharon ; Osgood, Greg M ; Lee, Olivia C ; Krause, Peter C ; Rowe, Cara J ; Hilliard, Colette L ; Morandi, Massimo Max ; Mullins, Angela ; Achor, Timothy S ; Choo, Andrew M ; Boutte, Sterling J ; Vallier, Heather A ; Breslin, Mary A ; Frisch, H. Michael ; Kaufman, Adam M ; Large, Thomas M ; LeCroy, C. Michael ; Phieffer, Laura S ; Sheridan, Elizabeth ; Sietsema, Debra L ; Reid, J. Spence ; Hayda, Roman ; Evans, Andrew R ; Rivera, Jessica C ; Osborn, Patrick M ; Kimmel, Joseph ; Stawicki, Stanislaw P ; Nwachuku, Chinenye O ; Wojda, Thomas R ; Rehman, Saqib ; Donnelly, Joanne M ; Caroom, Cyrus ; Boulton, Christina L ; Costales, Timothy G ; LeBrun, Christopher T ; Mascarenhas, Daniel C ; Berger, Peter Z ; Degani, Yasmin ; Howe, Andrea L ; Marinos, Dimitrius P ; Montalvo, Ryan N ; Reahl, G. Bradley ; Schroder, Lisa K ; Vang, Sandy ; Bergin, Patrick F ; Russell, George V ; Spitler, Clay A ; Teague, David ; Ertl, William ; Hickerson, Lindsay E ; Moloney, Gele B ; Weinlein, John C ; Agarwal, Animesh ; Karia, Ravi A ; Sathy, Ashoke K ; Maroto, Medardo ; Sanders, Drew ; Higgins, Thomas F ; Rothberg, David L ; Lester-Ballard, Veronica ; Whiting, Paul S ; Siy, Alexander B ; Obremskey, William T ; Jahangir, A. Alex ; Molina, Cesar S ; Rodriguez-Buitrago, Andres ; Gajari, Vamshi ; Trochez, Karen M ; Halvorson, Jason J ; Miller, Anna N ; Goodman, James Brett ; McAndrew, Christopher M ; Ricci, William M ; Spraggs-Hughes, Amanda ; Collins, Susan C ; Taylor, Tara J ; Zadnik, Mary</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a301t-bff99ce8697d5ae58e0df6e2fcec35bc6cc892ab229874daba232662cef36dce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Anti-Bacterial Agents - administration & dosage</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Antibiotics</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fracture Fixation, Internal - adverse effects</topic><topic>Fractures, Ununited - etiology</topic><topic>Gram-Negative Bacterial Infections - prevention & control</topic><topic>Gram-Positive Bacterial Infections - prevention & control</topic><topic>Humans</topic><topic>Intra-Articular Fractures - surgery</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Powders</topic><topic>Probability</topic><topic>Prospective Studies</topic><topic>Risk assessment</topic><topic>Risk factors</topic><topic>Studies</topic><topic>Surgery</topic><topic>Surgical outcomes</topic><topic>Surgical Wound Dehiscence - etiology</topic><topic>Surgical Wound Infection - etiology</topic><topic>Surgical Wound Infection - prevention & control</topic><topic>Tibial Fractures - surgery</topic><topic>Time Factors</topic><topic>Vancomycin - administration & dosage</topic><topic>Vancomycin - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>O’Toole, Robert V</creatorcontrib><creatorcontrib>Joshi, Manjari</creatorcontrib><creatorcontrib>Allen, Lauren E</creatorcontrib><creatorcontrib>Huang, Yanjie</creatorcontrib><creatorcontrib>Gary, Joshua L</creatorcontrib><creatorcontrib>Castillo, Renan C</creatorcontrib><creatorcontrib>Bishop, Julius A</creatorcontrib><creatorcontrib>Firoozabadi, Reza</creatorcontrib><creatorcontrib>Karunakar, Madhav A</creatorcontrib><creatorcontrib>Seymour, Rachel B</creatorcontrib><creatorcontrib>Sims, Stephen H</creatorcontrib><creatorcontrib>Churchill, Christine</creatorcontrib><creatorcontrib>Brennan, Michael L</creatorcontrib><creatorcontrib>Reilly, Rachel M</creatorcontrib><creatorcontrib>Howes, Cameron R</creatorcontrib><creatorcontrib>Mir, Hassan R</creatorcontrib><creatorcontrib>Kempton, Laurence B</creatorcontrib><creatorcontrib>Natoli, Roman M</creatorcontrib><creatorcontrib>Virkus, Walter W</creatorcontrib><creatorcontrib>Hymes, Robert A</creatorcontrib><creatorcontrib>Holzman, Michael</creatorcontrib><creatorcontrib>Malekzadeh, A. 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Alex</creatorcontrib><creatorcontrib>Molina, Cesar S</creatorcontrib><creatorcontrib>Rodriguez-Buitrago, Andres</creatorcontrib><creatorcontrib>Gajari, Vamshi</creatorcontrib><creatorcontrib>Trochez, Karen M</creatorcontrib><creatorcontrib>Halvorson, Jason J</creatorcontrib><creatorcontrib>Miller, Anna N</creatorcontrib><creatorcontrib>Goodman, James Brett</creatorcontrib><creatorcontrib>McAndrew, Christopher M</creatorcontrib><creatorcontrib>Ricci, William M</creatorcontrib><creatorcontrib>Spraggs-Hughes, Amanda</creatorcontrib><creatorcontrib>Collins, Susan C</creatorcontrib><creatorcontrib>Taylor, Tara J</creatorcontrib><creatorcontrib>Zadnik, Mary</creatorcontrib><creatorcontrib>Major Extremity Trauma Research Consortium (METRC)</creatorcontrib><creatorcontrib>The Major Extremity Trauma Research Consortium (METRC)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>Archives of surgery (Chicago. 1960)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>O’Toole, Robert V</au><au>Joshi, Manjari</au><au>Allen, Lauren E</au><au>Huang, Yanjie</au><au>Gary, Joshua L</au><au>Castillo, Renan C</au><au>Bishop, Julius A</au><au>Firoozabadi, Reza</au><au>Karunakar, Madhav A</au><au>Seymour, Rachel B</au><au>Sims, Stephen H</au><au>Churchill, Christine</au><au>Brennan, Michael L</au><au>Reilly, Rachel M</au><au>Howes, Cameron R</au><au>Mir, Hassan R</au><au>Kempton, Laurence B</au><au>Natoli, Roman M</au><au>Virkus, Walter W</au><au>Hymes, Robert A</au><au>Holzman, Michael</au><au>Malekzadeh, A. 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Spence</au><au>Hayda, Roman</au><au>Evans, Andrew R</au><au>Rivera, Jessica C</au><au>Osborn, Patrick M</au><au>Kimmel, Joseph</au><au>Stawicki, Stanislaw P</au><au>Nwachuku, Chinenye O</au><au>Wojda, Thomas R</au><au>Rehman, Saqib</au><au>Donnelly, Joanne M</au><au>Caroom, Cyrus</au><au>Boulton, Christina L</au><au>Costales, Timothy G</au><au>LeBrun, Christopher T</au><au>Mascarenhas, Daniel C</au><au>Berger, Peter Z</au><au>Degani, Yasmin</au><au>Howe, Andrea L</au><au>Marinos, Dimitrius P</au><au>Montalvo, Ryan N</au><au>Reahl, G. Bradley</au><au>Schroder, Lisa K</au><au>Vang, Sandy</au><au>Bergin, Patrick F</au><au>Russell, George V</au><au>Spitler, Clay A</au><au>Teague, David</au><au>Ertl, William</au><au>Hickerson, Lindsay E</au><au>Moloney, Gele B</au><au>Weinlein, John C</au><au>Agarwal, Animesh</au><au>Karia, Ravi A</au><au>Sathy, Ashoke K</au><au>Maroto, Medardo</au><au>Sanders, Drew</au><au>Higgins, Thomas F</au><au>Rothberg, David L</au><au>Lester-Ballard, Veronica</au><au>Whiting, Paul S</au><au>Siy, Alexander B</au><au>Obremskey, William T</au><au>Jahangir, A. Alex</au><au>Molina, Cesar S</au><au>Rodriguez-Buitrago, Andres</au><au>Gajari, Vamshi</au><au>Trochez, Karen M</au><au>Halvorson, Jason J</au><au>Miller, Anna N</au><au>Goodman, James Brett</au><au>McAndrew, Christopher M</au><au>Ricci, William M</au><au>Spraggs-Hughes, Amanda</au><au>Collins, Susan C</au><au>Taylor, Tara J</au><au>Zadnik, Mary</au><aucorp>Major Extremity Trauma Research Consortium (METRC)</aucorp><aucorp>The Major Extremity Trauma Research Consortium (METRC)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial</atitle><jtitle>Archives of surgery (Chicago. 1960)</jtitle><addtitle>JAMA Surg</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>156</volume><issue>5</issue><spage>e207259</spage><epage>e207259</epage><pages>e207259-e207259</pages><issn>2168-6254</issn><eissn>2168-6262</eissn><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</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>33760010</pmid><doi>10.1001/jamasurg.2020.7259</doi></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2168-6254 |
| ispartof | Archives of surgery (Chicago. 1960), 2021-05, Vol.156 (5), p.e207259-e207259 |
| issn | 2168-6254 2168-6262 |
| language | eng |
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| source | MEDLINE; American Medical Association Journals; Alma/SFX Local Collection |
| subjects | Adult Anti-Bacterial Agents - administration & dosage Anti-Bacterial Agents - therapeutic use Antibiotics Clinical trials Double-Blind Method Female Fracture Fixation, Internal - adverse effects Fractures, Ununited - etiology Gram-Negative Bacterial Infections - prevention & control Gram-Positive Bacterial Infections - prevention & control Humans Intra-Articular Fractures - surgery Male Middle Aged Powders Probability Prospective Studies Risk assessment Risk factors Studies Surgery Surgical outcomes Surgical Wound Dehiscence - etiology Surgical Wound Infection - etiology Surgical Wound Infection - prevention & control Tibial Fractures - surgery Time Factors Vancomycin - administration & dosage Vancomycin - therapeutic use |
| title | Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial |
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