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

1. Infection study - India
Infection rates following internal fixation in closed
tibia fractures in India
Sponsor: AOTK & Synthes Asia Pacific
Collaboration between AOCID & MC Master University (Ontario)
PCI – Dr. med. Prakash Doshi
Tanja Mannhart – Project Manager GRF One Health Summit 2012
19.-23. February

2. Rationale
Situation in newly
industrializing
countries
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3. Alarming increase in accidental injuries
leading to increasing number of orthopedic
procedures and infections after implant surgery
 Public health problem
 Disablement, social impact, hight treatment costs
Challenging setting:
 Late presentation  Poly-microbial load
 Poor environment  Gram-neg. and pos. infections
 Antibiotic restistances / MRSA
Quantification of infection risk and pattern as a base for
adapted treatment strategies needed!

4. Overview
Patients 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. 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. Secondary objectives
1. Infection management and infection treatment outcome
2. 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
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7. Secondary objectives
3. Assessment of health-related quality of life
parameter:
• EuroQol5
• SF-36
4. Complications
(Adverse events, serious adverse events)
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8. Literature search on Implant related infection rates in newly
industrializing countries – scarce information available
Localization and fracture- Infection
Ref. Country n
type rate
Kulshrest Open tibia fractures
ha India 30 6.7 %
(1) Gustillo I (10), II (14) III (6)
Closed fractures
Khan
Pakistan 104 5.8%
et al (2)
No classification
Closed fractures
Saris
Ghana 194 3.3 %
et al (3)
No classification
Open fractures 27
Steiner
Ethiopia (16 18.5%
et al (4)
Gustillo I (20), II (5) III (2) gunshots)
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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. MRSA
Singh Open
India pneumonia Pseudomona
et al (5) fractures 32 % 27% 13.6%
e 18% s
Qureshi Streptococc
Pakistan Osteomyelitis 54 % 23% 18 % -
et al (6) us 2.5%
Haque Surgical site
India 15% 63% 22% - Gram neg.
et al (7) infections
Agrawal Mainly open
India 22% 49% 26% - Gram neg.
et al (8) fractures
Malik 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. 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
citizens
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11. Indian hospitals
Gross disparity between trauma care services
across the country.
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12. Public hospitals
• Only 15% of Indian hospitals
• Free health care
• Underfunded by state & overcrowded
Private hospitals
• Large private health sector
• Cost of treatment is mostly covered by the
patients and their families
Out of pocket expenditures at the point of
service account for more than 70% of health
expenditures
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13. Selection of clinics
Representativeness Feasibility
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14. Diagnostic approach to determine the
presence of infection
• Any evidence of
infection has to be
documented
• Clarification whether
infection is present
according to
CDC/NHSN
Classification for
surgical site infection
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15. Diagnostic approach to determine the
presence of infection
If 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. Rx
SSI Surgical Site Infection
ESR Erythrocyte sedimentation rate
CRP C-reactive protein, liver protein
(10) GOEL; Indian J Orthop; 2006
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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
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17. Classification of surgical site infections
(SSI)
2. Related to timing of onset
Onset of
Classification Characteristics
symptoms
Predominantly acquired during trauma or
Early implant surgery, caused by highly virulent
< 2 weeks
infection organisms (eg, S. aureus, Gram-negative
bacilli)
Delayed Predominantly acquired during trauma or
2-10 weeks
infection implant surgery and caused by low
virulence organisms (eg, coagulase-
negative staphylococci); occasionally
Late 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.
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18. Infection occurrence
Judgement whether the infection has occurred is
decided by a blinded Central Outcomes Adjudication
Committee based on diagnostic results available from
the clinic.
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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. Thank you for your attention!
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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. J
Ayub 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 in
a 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 nosocomial
infections 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. Biomedica
2009;25:180-3.
(7) Haque R, Salam MA. Detection of ESBL producing nosocomial gram negative bacteria from a tertiary care hospital
in 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 Countries
2008;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 1992
Oct;13(10):606-8.
(12) Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and
criteria 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 2006
May;37 Suppl 2:S59-S66.
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