Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Обзор

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.

Подробное описание

Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection.

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.

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.

The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization.

One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN).

Participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Вмешательства

• Препарат Antibiotic coated intramedullary Nail
  Antibiotic coated intramedullary nail: A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.
• Другое Standard Intramedullary Nail
  Standard Intramedullary Nail

Первичные конечные точки

• Number of Participants who develop deep surgical site infection (SSI) [Срок оценки: Day 30 through month 12]

Вторичные конечные точки (12)

• Radiographic Union Scale in Tibial fractures (RUST) score [Срок оценки: week 6, month 3, month 6, and month 12]
• Percentage of Union [Срок оценки: week 6, month 3, month 6 and month12]
• Time to Union [Срок оценки: week 6, month 3, month 6 and month12]
• Average Time to Return to Work/Duty [Срок оценки: week 6, month 3, month 6 and month12]
• International Physical Activity Questionnaire (IPAQ) [Срок оценки: week 6, month 3, month 6 and month12]
• Number of Subjects Who Have Returned to Work [Срок оценки: week 6, month 3, month 6 and month12]
• Number of Participants who Return to Operating Room (OR) [Срок оценки: Month 12]
• PROMIS-29 Subscale--Physical Function [Срок оценки: week 6, month 3, month 6 and month12]
• PROMIS-29 Subscale--Physical Function: Anxiety [Срок оценки: week 6, month 3, month 6 and month12]
• PROMIS-29 Subscale--Depression [Срок оценки: week 6, month 3, month 6 and month12]
• PROMIS-29 Subscale--Fatigue [Срок оценки: week 6, month 3, month 6 and month12]
• PROMIS-29 Subscale--Sleep Disturbance [Срок оценки: week 6, month 3, month 6 and month12]

Критерии участия

Критерии включения

• Patients 18 years or older
• Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail

Критерии исключения

• Less than 18 years of age
• Allergy to vancomycin or gentamicin
• Unable to speak English or Spanish
• Pregnant and lactating women
• Prisoner
• Unable to follow up for 12 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 14 центров

• University of Florida Gainesville — Gainesville
• Florida Orthopaedic Institute — Temple Terrace
• Atrium Health Navicent — Macon
• University of Kentucky — Lexington
• University of North Carolina Chapel Hill — Chapel Hill
• Atrium Health Carolinas Medical Center — Charlotte
• Atrium Health Cabarrus — Concord
• Atrium Health Wake Forest Baptist — Winston-Salem
• … и ещё 6 центров

Публикации

• 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. PMID 17414553
• 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. PMID 22491628
• 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. PMID 12477942
• 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. PMID 25159355
• 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. PMID 17638186
• 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. PMID 17916782
• 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. PMID 28323794
• 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. PMID 21795886

Идентификаторы

NCT: NCT05421741 · IRB00086285 · 01012022 · 40010222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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