Project to determine infection rates following internal fixation in closed tibia fractures in India


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GRF One Health Summit 2012, Davos: Presentation by Tanja MANNHART, AO Foundation, Switzerland

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Project to determine infection rates following internal fixation in closed tibia fractures in India

  1. 1. Infection study - IndiaInfection rates following internal fixation in closedtibia fractures in IndiaSponsor: AOTK & Synthes Asia PacificCollaboration between AOCID & MC Master University (Ontario)PCI – Dr. med. Prakash DoshiTanja Mannhart – Project Manager GRF One Health Summit 2012 19.-23. February
  2. 2. RationaleSituation in newlyindustrializingcountries2
  3. 3. Alarming increase in accidental injuriesleading to increasing number of orthopedicprocedures and infections after implant surgery Public health problem Disablement, social impact, hight treatment costsChallenging setting: Late presentation  Poly-microbial load Poor environment  Gram-neg. and pos. infections  Antibiotic restistances / MRSAQuantification of infection risk and pattern as a base foradapted treatment strategies needed!
  4. 4. OverviewPatients Patients with closed tibia fracture AO 41- 44 Prospective, observational Multicenter study: 10 clinics Sample size: max. 1,000 patients (50 infections)Intervention Internal fixation (plate, nail)
  5. 5. Primary objectives 1. Overall surgical infection rate after implant surgery • Bacteriology: type of infection (germs), antibiotic sensitivity(*) Def. according to Centers for Disease Control and Prevention, Atlanta (10,11)
  6. 6. Secondary objectives1. Infection management and infection treatment outcome2. The influence of the following clinic and patient factors on the occurrence of infection: • Hospital standard hygienic & antibiotic protocol for infection prevention • Patient demographics • Time between injury and surgery and between admission and surgery • Fracture type (Müller AO classification) • Soft tissue damage (Tscherne classification) • Fracture management and implant type • Surgical details such as duration of surgery 6
  7. 7. Secondary objectives3. Assessment of health-related quality of life parameter: • EuroQol5 • SF-364. Complications (Adverse events, serious adverse events) 7
  8. 8. Literature search on Implant related infection rates in newlyindustrializing countries – scarce information available Localization and fracture- Infection Ref. Country n type rateKulshrest Open tibia fracturesha India 30 6.7 %(1) Gustillo I (10), II (14) III (6) Closed fracturesKhan Pakistan 104 5.8%et al (2) No classification Closed fracturesSaris Ghana 194 3.3 %et al (3) No classification Open fractures 27Steiner Ethiopia (16 18.5%et al (4) Gustillo I (20), II (5) III (2) gunshots) 8
  9. 9. Literature search on microbiological isolates as reported by orthopedic clinics in India and Pakistan Infection Enterobac Pseudo- Antibiotic Ref. Country S.aureus other type teriaceae monas resistancies K. MRSASingh Open India pneumonia Pseudomonaet al (5) fractures 32 % 27% 13.6% e 18% sQureshi Streptococc Pakistan Osteomyelitis 54 % 23% 18 % -et al (6) us 2.5%Haque Surgical site India 15% 63% 22% - Gram al (7) infectionsAgrawal Mainly open India 22% 49% 26% - Gram al (8) fracturesMalik 3% Pakistan Osteomyelitis 29% 33% 15% -(9) anaerobes Main problem of surgical site infections are Staph. Aureus MRSA are reported in Indian hospitals Gram negative bacteria gain foothold (E.coli, Pseudomonas)
  10. 10. Why India?World’s second largest population (1 billion people)Newly industrialized country• Alarming increase in accidental injuries• Rapidly growing economy (GDP growth 2010-2011: 8.5%)• Better income  more people have access to surgery• But: inadequate access to proper health care for poor citizens10
  11. 11. Indian hospitalsGross disparity between trauma care servicesacross the country.11
  12. 12. Public hospitals• Only 15% of Indian hospitals• Free health care• Underfunded by state & overcrowdedPrivate hospitals• Large private health sector• Cost of treatment is mostly covered by the patients and their familiesOut of pocket expenditures at the point ofservice account for more than 70% of healthexpenditures12
  13. 13. Selection of clinicsRepresentativeness Feasibility 13
  14. 14. Diagnostic approach to determine thepresence of infection• Any evidence of infection has to be documented• Clarification whether infection is present according to CDC/NHSN Classification for surgical site infection14
  15. 15. Diagnostic approach to determine thepresence of infectionIf symptoms for SSI are present:1. Performance of laboratory tests: - Bacterial culture of aspirate - e.v. blood culture - Leukocyte count / Diff. - CRP level (repeated testing) - ESR level (repeated testing)2. Diagnostic imaging: e.g. RxSSI Surgical Site InfectionESR Erythrocyte sedimentation rateCRP C-reactive protein, liver protein(10) GOEL; Indian J Orthop; 200615
  16. 16. Classification of surgical site infections (SSI)1. CDC/NHSN Classification based on location Superficial incisional SSI Deep incisional SSI occurs within 30 days post-op occurs within 30 days post-op if no skin + subcutis affected implant is left in place or within 1 year if implant is in place purulent drainage from superficial incision deep soft tissue affected (e.g. fascial + positive bacterial culture muscle layers)isolated pain, redness, localized swelling purulent drainage from deep incision or abscess positive bacterial culture fever > 38°C, localized pain (11, 12) Horan et al.*; Am J Infect Control; 2008 (*) Centres for Disease Control and Prevention, Atlnanda 16
  17. 17. Classification of surgical site infections(SSI)2. Related to timing of onset Onset ofClassification Characteristics symptoms Predominantly acquired during trauma orEarly implant surgery, caused by highly virulent < 2 weeksinfection organisms (eg, S. aureus, Gram-negative bacilli)Delayed Predominantly acquired during trauma or 2-10 weeksinfection implant surgery and caused by low virulence organisms (eg, coagulase- negative staphylococci); occasionallyLate infection > 10 weeks caused by haematogenous seeding from remote infections (13) Trampuz A, Zimmerli W. Diagnosis and treatment of infections associated with fracture-fixation devices. Injury 2006 May;37 Suppl 2:S59-S66.17
  18. 18. Infection occurrenceJudgement whether the infection has occurred isdecided by a blinded Central Outcomes AdjudicationCommittee based on diagnostic results available fromthe clinic.18
  19. 19. Possible study adjustments in 2012• Adjusted inclusion criteria  also include open fractures• Fewer follow-ups  after 3, 6 and 12 months• Interim analysis  after 300 patients• Limit of one health-related quality of life questionnaire  EQ-5D
  20. 20. Thank you for your attention!20
  21. 21. References(1) Kulshrestha V. Incidence of infection after early intramedullary nailing of open tibial shaft fractures stabilized with pinless external fixators. Indian J Orthop 2008 Oct;42(4):401-9.(2) Khan MS, ur RS, Ali MA, Sultan B, Sultan S. Infection in orthopedic implant surgery, its risk factors and outcome. JAyub Med Coll Abbottabad 2008 Jan;20(1):23-5.(3) Saris CG, Bastianen CA, Mvan Swieten EC, Wegdam HH. Infection rate in closed fractures after internal fixations ina municipal hospital in Ghana. Trop Doct 2006 Oct;36(4):233-5.(4) Steiner A, Kotisso B. Open fractures and internal fixation in a major African hospital. Injury 1996;27(No. 9):625-30.(5) Singh R, Sikka R, Maggu NK. Prevalence and antibiotic sensitivity pattern of bacteria isolated from nosocomialinfections in orthpaedic patients. J Orthopaedics 2010;7(2)e3.(6) Qureshi M, Chuadry S, Haroon S. Bacterial aetiology of bone lesions, in a tertiary care hospital. Biomedica2009;25:180-3.(7) Haque R, Salam MA. Detection of ESBL producing nosocomial gram negative bacteria from a tertiary care hospitalin Bangladesh. Pak J Med Sci 2010;26(No.4):887-91.(8) Agrawal A.C., Jain S. Pathogenic bacteria in an orthopaedic hospital in India. J Infect Developing Countries2008;2(2):120-3.(9) Faria Malik. Bacterial aetiology of osteomyelitis cases at four hospitals of Lahore. JAMC 2003;15(2)(April-June).10) Goel SC. Infection following implant surgery. current concept review. 40[3], 133-137. 2006. Indian J Orthop.(11)Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections,1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 1992Oct;13(10):606-8.(12) Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection andcriteria for specific types of infections in the acute care setting. Am J Infect Control 2008 Jun;36(5):309-32.(13) Trampuz A, Zimmerli W. Diagnosis and treatment of infections associated with fracture-fixation devices. Injury 2006May;37 Suppl 2:S59-S66.21