Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Summary

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

Timeline

Start

2023-05-15

Primary completion

2026-12

Completion

2027-12

Publications

• Results Owens BD, Kragh JF Jr, Macaitis J, Svoboda SJ, Wenke JC. Characterization of extremity wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Orthop Trauma. 2007 Apr;21(4):254-7. doi: 10.1097/BOT.0b013e31802f78fb.
• Results Burns TC, Stinner DJ, Mack AW, Potter BK, Beer R, Eckel TT, Possley DR, Beltran MJ, Hayda RA, Andersen RC, Keeling JJ, Frisch HM, Murray CK, Wenke JC, Ficke JR, Hsu JR; Skeletal Trauma Research Consortium. Microbiology and injury characteristics in severe open tibia fractures from combat. J Trauma Acute Care Surg. 2012 Apr;72(4):1062-7. doi: 10.1097/TA.0b013e318241f534.
• Results Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002 Dec 12;347(24):1924-31. doi: 10.1056/NEJMoa012604.
• Results Napierala MA, Rivera JC, Burns TC, Murray CK, Wenke JC, Hsu JR; Skeletal Trauma Research Education Consortium (STReC). Infection reduces return-to-duty rates for soldiers with Type III open tibia fractures. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S194-7. doi: 10.1097/TA.0000000000000364.
• Results Johnson EN, Burns TC, Hayda RA, Hospenthal DR, Murray CK. Infectious complications of open type III tibial fractures among combat casualties. Clin Infect Dis. 2007 Aug 15;45(4):409-15. doi: 10.1086/520029. Epub 2007 Jul 5.
• Results Ficke JR, Pollak AN. Extremity War Injuries: Development of Clinical Treatment Principles. J Am Acad Orthop Surg. 2007 Oct;15(10):590-5. doi: 10.5435/00124635-200710000-00003.
• Results Section 1: Preventing and Managing Infection and Other Complications After Orthopaedic Trauma. J Orthop Trauma. 2017 Apr;31 Suppl 1:S2. doi: 10.1097/BOT.0000000000000798. No abstract available.
• Results Masini BD, Owens BD, Hsu JR, Wenke JC. Rehospitalization after combat injury. J Trauma. 2011 Jul;71(1 Suppl):S98-102. doi: 10.1097/TA.0b013e3182218fbc.
• Results Huh J, Stinner DJ, Burns TC, Hsu JR; Late Amputation Study Team. Infectious complications and soft tissue injury contribute to late amputation after severe lower extremity trauma. J Trauma. 2011 Jul;71(1 Suppl):S47-51. doi: 10.1097/TA.0b013e318221181d.
• Results Cross JD, Stinner DJ, Burns TC, Wenke JC, Hsu JR; Skeletal Trauma Research Consortium (STReC). Return to duty after type III open tibia fracture. J Orthop Trauma. 2012 Jan;26(1):43-7. doi: 10.1097/BOT.0b013e31821c0ec1.
• Results Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. doi: 10.1086/421095. Epub 2004 May 26.
• Results Pinto D, Manjunatha K, Savur AD, Ahmed NR, Mallya S, Ramya V. Comparative study of the efficacy of gentamicin-coated intramedullary interlocking nail versus regular intramedullary interlocking nail in Gustilo type I and II open tibia fractures. Chin J Traumatol. 2019 Oct;22(5):270-273. doi: 10.1016/j.cjtee.2019.03.006. Epub 2019 Jun 21.
• Results Schmidmaier G, Kerstan M, Schwabe P, Sudkamp N, Raschke M. Clinical experiences in the use of a gentamicin-coated titanium nail in tibia fractures. Injury. 2017 Oct;48(10):2235-2241. doi: 10.1016/j.injury.2017.07.008. Epub 2017 Jul 10.
• Results Jorge-Mora A, Amhaz-Escanlar S, Fernandez-Pose S, Garcia-Iglesias A, Mandia-Mancebo F, Franco-Trepat E, Guillan-Fresco M, Pino-Minguez J. Commercially available antibiotic-laden PMMA-covered locking nails for the treatment of fracture-related infections - A retrospective case analysis of 10 cases. J Bone Jt Infect. 2019 Jul 5;4(4):155-162. doi: 10.7150/jbji.34072. eCollection 2019.
• Results Shiels SM, Mangum LH, Wenke JC. Revisiting the "race for the surface" in a pre-clinical model of implant infection. Eur Cell Mater. 2020 Jan 29;39:77-95. doi: 10.22203/eCM.v039a05.
• Results Lin WT, Tan HL, Duan ZL, Yue B, Ma R, He G, Tang TT. Inhibited bacterial biofilm formation and improved osteogenic activity on gentamicin-loaded titania nanotubes with various diameters. Int J Nanomedicine. 2014 Mar 7;9:1215-30. doi: 10.2147/IJN.S57875. eCollection 2014.
• Results Mauffrey C, Butler N, Hake ME. Fabrication of an Interlocked Antibiotic/Cement-Coated Carbon Fiber Nail for the Treatment of Long Bone Osteomyelitis. J Orthop Trauma. 2016 Aug;30 Suppl 2:S23-4. doi: 10.1097/BOT.0000000000000587.
• Results Thonse R, Conway J. Antibiotic cement-coated interlocking nail for the treatment of infected nonunions and segmental bone defects. J Orthop Trauma. 2007 Apr;21(4):258-68. doi: 10.1097/BOT.0b013e31803ea9e6.
• Results Barger J, Fragomen AT, Rozbruch SR. Antibiotic-Coated Interlocking Intramedullary Nail for the Treatment of Long-Bone Osteomyelitis. JBJS Rev. 2017 Jul;5(7):e5. doi: 10.2106/JBJS.RVW.16.00095. No abstract available.
• Results O'Toole R, Joshi M, Carlini A, et al. Multicenter Randomized Trial Evaluating Intrawound Vancomycin Powder for Reducing Surgical Site Infection After Fracture Surgery. Orthopaedic Trauma Association; 2018; Orlando, FL
• Results Caroom C, Tullar JM, Benton EG Jr, Jones JR, Chaput CD. Intrawound vancomycin powder reduces surgical site infections in posterior cervical fusion. Spine (Phila Pa 1976). 2013 Jun 15;38(14):1183-7. doi: 10.1097/BRS.0b013e31828fcfb5.
• Results Carver DC, Kuehn SB, Weinlein JC. Role of Systemic and Local Antibiotics in the Treatment of Open Fractures. Orthop Clin North Am. 2017 Apr;48(2):137-153. doi: 10.1016/j.ocl.2016.12.005. Epub 2017 Jan 30.
• Results O'Toole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Scharfstein DO, Gary JL, Bosse MJ, Castillo RC; METRC. Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter, Randomized, Controlled Trial (VANCO Study). J Orthop Trauma. 2017 Apr;31 Suppl 1:S18-S24. doi: 10.1097/BOT.0000000000000801.
• Results Hanssen AD, Osmon DR, Patel R. Local antibiotic delivery systems: where are we and where are we going? Clin Orthop Relat Res. 2005 Aug;(437):111-4. No abstract available.
• Results Shiels SM, Tennent DJ, Lofgren AL, Wenke JC. Topical rifampin powder for orthopaedic trauma part II: Topical rifampin allows for spontaneous bone healing in sterile and contaminated wounds. J Orthop Res. 2018 Dec;36(12):3142-3150. doi: 10.1002/jor.24155. Epub 2018 Oct 29.
• Results Tennent DJ, Shiels SM, Sanchez CJ Jr, Niece KL, Akers KS, Stinner DJ, Wenke JC. Time-Dependent Effectiveness of Locally Applied Vancomycin Powder in a Contaminated Traumatic Orthopaedic Wound Model. J Orthop Trauma. 2016 Oct;30(10):531-7. doi: 10.1097/BOT.0000000000000617.
• Results Shiels SM, Tennent DJ, Wenke JC. Topical rifampin powder for orthopedic trauma part I: Rifampin powder reduces recalcitrant infection in a delayed treatment musculoskeletal trauma model. J Orthop Res. 2018 Dec;36(12):3136-3141. doi: 10.1002/jor.24055. Epub 2018 Oct 5.
• Results Berger ML, Dreyer N, Anderson F, Towse A, Sedrakyan A, Normand SL. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health. 2012 Mar-Apr;15(2):217-30. doi: 10.1016/j.jval.2011.12.010.
• Results Dreyer NA, Tunis SR, Berger M, Ollendorf D, Mattox P, Gliklich R. Why observational studies should be among the tools used in comparative effectiveness research. Health Aff (Millwood). 2010 Oct;29(10):1818-25. doi: 10.1377/hlthaff.2010.0666.
• Results Centers for Disease Control and Prevention. Surgical Site Infection (SSI) Event, January 2018. National Healthcare Safety Network. 2018
• Results Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
• Results Whelan DB, Bhandari M, Stephen D, Kreder H, McKee MD, Zdero R, Schemitsch EH. Development of the radiographic union score for tibial fractures for the assessment of tibial fracture healing after intramedullary fixation. J Trauma. 2010 Mar;68(3):629-32. doi: 10.1097/TA.0b013e3181a7c16d.
• Results Kooistra BW, Dijkman BG, Busse JW, Sprague S, Schemitsch EH, Bhandari M. The radiographic union scale in tibial fractures: reliability and validity. J Orthop Trauma. 2010 Mar;24 Suppl 1:S81-6. doi: 10.1097/BOT.0b013e3181ca3fd1.
• Results Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
• Results Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
• Results Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
• Results Schalet BD, Rothrock NE, Hays RD, Kazis LE, Cook KF, Rutsohn JP, Cella D. Linking Physical and Mental Health Summary Scores from the Veterans RAND 12-Item Health Survey (VR-12) to the PROMIS((R)) Global Health Scale. J Gen Intern Med. 2015 Oct;30(10):1524-30. doi: 10.1007/s11606-015-3453-9. Epub 2015 Jul 16.
• Results Selim AJ, Rogers W, Fleishman JA, Qian SX, Fincke BG, Rothendler JA, Kazis LE. Updated U.S. population standard for the Veterans RAND 12-item Health Survey (VR-12). Qual Life Res. 2009 Feb;18(1):43-52. doi: 10.1007/s11136-008-9418-2. Epub 2008 Dec 3.

Drugs

Indications