Медицинская библиотека · JAMA · 2026

Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures: The TOBRA Randomized Clinical Trial.

Major Extremity Trauma Research Consortium (METRC), O'Toole Robert V, O'Hara Nathan N, Carlini Anthony R, Schrank Gregory M, Chung Suna, Gary Joshua L, Obremskey William, Matuszewski Paul Edward, Teague David, Natoli Roman M, Gitajn Ida Leah, Weaver Michael J, Renninger Christopher H, Levack Ashley Elizabeth, Degani Yasmin, Collins Susan C, Weston-Farber Elias, Howe Andrea L, Thompson Richard E, Castillo Renan C, Karunakar Madhav A, Blum Laura, Harmer Luke, Hsu Joseph R, Kempton Laurence B, Phelps Kevin D, Seymour Rachel B, Sims Stephen H, Acharya Maithili S, Callahan Hayden, Chavez-Araujo Luz M, Churchill Christine, Gambuzza Michael P, Haim Kara R, Ishman Enosh, Kendall Joshua S, Mullis Nicholas D, Young Catherine, Pilson Holly T, Carroll Eben A, Goodman James Brett, Holden Martha B, Jones Alan L, Moon Charles, Lin Carol A, Marecek Geoffrey S, Moffitt Gable B, Conlan Todd, George Albert V, Fisher Lillian Adelaide, Mullin Devin S, Recendez Chelsey L, Aneja Arun, Brameier Devon T, Heng Marilyn, Ly Thuan V, Stenquist Derek S, Suneja Nishant, Wignakumar Thirushan, Borgida Jacob S, Policicchio Thomas J, Hanson George R, Alese Olutayo M, Ricci William M, Behrens Steve B, Dvorzhinskiy Aleksey, Bilodeau Robert E, Klinger Craig E, Mullis Brian H, Jang Yohan, Lopas Luke A, McKinley Todd O, O'Neill Dillon C, Szatkowski Jan P, Virkus Walter W, Hill Lauren C, Gaski Greg, Hymes Robert A, Ahn James, Goch Abraham M, Holzman Michael, Malekzadeh A Stephen, Schulman Jeff E, Rivera Jessica C, Krause Peter C, Bridgman Carolyn, Cohen Joseph, Eikani Carlo, Chavez Maria, Kudulis Michelle, Warner Stephen J, Achor Timothy S, Choo Andrew, Eastman Jonathan G, Kellam Patrick J, Boutte Sterling J, Guevara Keyla Denniss, Reid Kristoff R, Vallier Heather A, Tucci Anna Vergon, Davis Jana M, Bell Alice C, Bonyun Marissa E, Healey Kathleen, Li Vivian, McKibben Natasha S, Nascone Jason, Okhuereigbe David, Sciadini Marcus F, Slobogean Gerard, Zingas Nicolas, Kovvur Murali, Lawrence Joshua E, Phipps Heather, Rudnicki Joshua, Turner Kristin E, Hayda Roman, Evans Andrew R, Quinnan Stephen, Benitez Alyha, Rehman Saqib, Soderquist Melissa C, Townsend Clay B, Caroom Cyrus, Collins Angela C, Okwumabua Ebubechi, Shaikh Humza S, Spitler Clay A, Agarwal Abhinav, Johnson Michael D, Haller Justin M, Marchand Lucas S, Alfonso Nicholas A, Gorman Melissa A, Charlton William Michael, Scott Brandon R, Kraus Kameron M, Meredith Sean J, Talwar Sneh, Bergin Patrick F, Jha Aaradhana J, McGee Sheketha, Nehete Priyanka V, Pryor Tyranny A, Spears Isaac, Chen Andrew T, Kelley Benjamin, Nez Nevaeh R, Ertl William J, Hull Brandon R, Blumenthal Sarah, Patterson Joseph T, Flynn Camille, Ross Ryan C, Agarwal Animesh, Weiss David B, Hadeed Michael M, Yarboro Seth R, Daoud Tina, McVey Eric D, Whiting Paul S, Domes Christopher, Goodspeed David C, Kuhn Gabrielle R, Boyce Robert, Libos Andres, Mitchell Phillip M, Moreno-Diaz Andres Fidel, Ponce Robert Brandon, Stinner Daniel J, Tatman Lauren M, Velasco-Castro Juanita, Trochez Karen, Satpathy Jibanananda, Zuelzer David A, Potter Benjamin K

Клиническое исследование III фазыСравнительное исследованиеEquivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод в очереди

Аннотация

IMPORTANCE

Previous research has suggested that intrawound vancomycin powder reduces deep surgical site infections among patients with periarticular tibial fractures at high risk of infection. It is unknown whether the addition of tobramycin powder further decreases infection rates.

OBJECTIVE

To compare whether the combination of tobramycin plus vancomycin vs vancomycin alone delivered as intrawound powder at the time of definitive fixation reduces deep surgical site infections.

DESIGN, SETTING, AND

PARTICIPANTS

Open-label, assessor-masked, randomized clinical trial conducted at 39 US trauma centers. Eligible patients were adults with an operatively treated periarticular tibial fracture (either tibial plateau or pilon) who met 1 of 3 criteria for elevated infection risk. Enrollment occurred between June 18, 2021, and December 12, 2024 (final follow-up, July 15, 2025).

INTERVENTIONS: Intrawound tobramycin (1.2 g) plus vancomycin (1.0 g) powder vs intrawound vancomycin (1.0 g) powder delivered at the time of definitive fixation.

MAIN OUTCOMES AND MEASURES: The primary outcome was a deep surgical site infection requiring surgical management within 182 days of definitive fracture fixation. Secondary outcomes included deep surgical site infections with pathogens that were gram-negative only, deep surgical site infections with at least 1 pathogen that was gram-positive, deep surgical site infections with polymicrobial cultures, deep surgical site infections with negative culture results, and cellulitis or skin infections treated only with antibiotics.

RESULTS

Among the 1660 participants randomized, 1528 (mean age, 47.0 [SD, 14.3] years; 603 female [39.5%]; 925 male [60.5%]) were included in the primary analysis. Deep surgical site infections occurred in 51 of 753 participants (182-day probability, 7.4%) in the tobramycin plus vancomycin group and 47 of 775 participants (182-day probability, 6.6%) in the vancomycin alone group (hazard ratio, 1.11; 95% bayesian credible interval, 0.75-1.66; posterior probability of superiority, 29.7%). The threshold required for superiority was not reached for any secondary outcome.

CONCLUSIONS AND RELEVANCE: Among patients with operatively treated periarticular tibial fractures at high risk of infection, adding intrawound tobramycin powder to vancomycin powder at the time of definitive fixation did not reduce deep surgical site infections compared with vancomycin powder alone.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02227446.

Для цитирования: Major Extremity Trauma Research Consortium (METRC), O'Toole Robert V, O'Hara Nathan N, Carlini Anthony R, Schrank Gregory M, Chung Suna, Gary Joshua L, Obremskey William, Matuszewski Paul Edward, Teague David, Natoli Roman M, Gitajn Ida Leah, Weaver Michael J, Renninger Christopher H, Levack Ashley Elizabeth, Degani Yasmin, Collins Susan C, Weston-Farber Elias, Howe Andrea L, Thompson Richard E, Castillo Renan C, Karunakar Madhav A, Blum Laura, Harmer Luke, Hsu Joseph R, Kempton Laurence B, Phelps Kevin D, Seymour Rachel B, Sims Stephen H, Acharya Maithili S, Callahan Hayden, Chavez-Araujo Luz M, Churchill Christine, Gambuzza Michael P, Haim Kara R, Ishman Enosh, Kendall Joshua S, Mullis Nicholas D, Young Catherine, Pilson Holly T, Carroll Eben A, Goodman James Brett, Holden Martha B, Jones Alan L, Moon Charles, Lin Carol A, Marecek Geoffrey S, Moffitt Gable B, Conlan Todd, George Albert V, Fisher Lillian Adelaide, Mullin Devin S, Recendez Chelsey L, Aneja Arun, Brameier Devon T, Heng Marilyn, Ly Thuan V, Stenquist Derek S, Suneja Nishant, Wignakumar Thirushan, Borgida Jacob S, Policicchio Thomas J, Hanson George R, Alese Olutayo M, Ricci William M, Behrens Steve B, Dvorzhinskiy Aleksey, Bilodeau Robert E, Klinger Craig E, Mullis Brian H, Jang Yohan, Lopas Luke A, McKinley Todd O, O'Neill Dillon C, Szatkowski Jan P, Virkus Walter W, Hill Lauren C, Gaski Greg, Hymes Robert A, Ahn James, Goch Abraham M, Holzman Michael, Malekzadeh A Stephen, Schulman Jeff E, Rivera Jessica C, Krause Peter C, Bridgman Carolyn, Cohen Joseph, Eikani Carlo, Chavez Maria, Kudulis Michelle, Warner Stephen J, Achor Timothy S, Choo Andrew, Eastman Jonathan G, Kellam Patrick J, Boutte Sterling J, Guevara Keyla Denniss, Reid Kristoff R, Vallier Heather A, Tucci Anna Vergon, Davis Jana M, Bell Alice C, Bonyun Marissa E, Healey Kathleen, Li Vivian, McKibben Natasha S, Nascone Jason, Okhuereigbe David, Sciadini Marcus F, Slobogean Gerard, Zingas Nicolas, Kovvur Murali, Lawrence Joshua E, Phipps Heather, Rudnicki Joshua, Turner Kristin E, Hayda Roman, Evans Andrew R, Quinnan Stephen, Benitez Alyha, Rehman Saqib, Soderquist Melissa C, Townsend Clay B, Caroom Cyrus, Collins Angela C, Okwumabua Ebubechi, Shaikh Humza S, Spitler Clay A, Agarwal Abhinav, Johnson Michael D, Haller Justin M, Marchand Lucas S, Alfonso Nicholas A, Gorman Melissa A, Charlton William Michael, Scott Brandon R, Kraus Kameron M, Meredith Sean J, Talwar Sneh, Bergin Patrick F, Jha Aaradhana J, McGee Sheketha, Nehete Priyanka V, Pryor Tyranny A, Spears Isaac, Chen Andrew T, Kelley Benjamin, Nez Nevaeh R, Ertl William J, Hull Brandon R, Blumenthal Sarah, Patterson Joseph T, Flynn Camille, Ross Ryan C, Agarwal Animesh, Weiss David B, Hadeed Michael M, Yarboro Seth R, Daoud Tina, McVey Eric D, Whiting Paul S, Domes Christopher, Goodspeed David C, Kuhn Gabrielle R, Boyce Robert, Libos Andres, Mitchell Phillip M, Moreno-Diaz Andres Fidel, Ponce Robert Brandon, Stinner Daniel J, Tatman Lauren M, Velasco-Castro Juanita, Trochez Karen, Satpathy Jibanananda, Zuelzer David A, Potter Benjamin K. Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures: The TOBRA Randomized Clinical Trial.. JAMA. 2026. DOI: 10.1001/jama.2026.4023.

Предметные рубрики MeSH

Adult Female Humans Male Middle Aged Anti-Bacterial Agents Antibiotic Prophylaxis Drug Therapy, Combination Powders Surgical Wound Infection Tibial Fractures Tobramycin Vancomycin Fracture Fixation, Internal United States Trauma Centers

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