Incidence of infection following internal fixation of open and closed tibia fractures in India (INFINITI): a multi-centre observational cohort study

Prakash Doshi, Hitesh Gopalan, Sheila Sprague, Chetan Pradhan, Sunil Kulkarni, Mohit Bhandari, Prakash Doshi, Hitesh Gopalan, Sheila Sprague, Chetan Pradhan, Sunil Kulkarni, Mohit Bhandari

Abstract

Background: Trauma is a major public health problem, particularly in India due to the country's rapid urbanization. Tibia fractures are a common and often complicated injury that is at risk of infection following surgical fixation. The primary objectives of this cohort study were to determine the incidence of infection within one year of surgery and to describe the distribution of infections by location and time of diagnosis for tibia fractures in India.

Methods: We conducted a multi-center, prospective cohort study. Patients who presented with an open or closed tibia fracture treated with internal fixation to one of the participating hospitals in India were invited to participate in the study. Participants attended follow-up visits at 3, 6, and 12 months post-surgery, where they were assessed for infections, fracture healing, and health-related quality of life as measured by the EurQol-5 Dimensions (EQ-5D).

Results: Seven hundred eighty-seven participants were included in the study and 768 participants completed the 12 month follow-up. The overall incidence of infection was 2.9% (23 infections). The incidence of infection was 1.6% (10 infections) in closed and 8.0% (13 infections) in open fractures. There were 7 deep and 16 superficial infections, with 5 being early, 7 being delayed, and 11 being late infections. Intra-operative antibiotics were given to 92.1% of participants and post-operative antibiotics were given to 96.8% of participants. Antibiotics were prescribed for an average of 8.3 days for closed fractures and 9.1 days for open fractures. Infected fractures took significantly longer to heal, and participants who had an infection had significantly lower EQ-5D scores.

Conclusions: The incidence of infection within this cohort is similar to those seen in developed countries. The duration of prophylactic antibiotic use was longer than standard practice in North America, raising concern for the potential development of antibiotic resistant microbes within Indian orthopaedic settings. Future research should aim to identify the best practice for antibiotic use in India to ensure that antibiotic usage patterns do not lead to unnecessary overuse, while maintaining a low incidence of infection.

Trial registration: NCT01691599 , September 17, 2012.

Keywords: Closed tibia fractures; Open tibia fractures; Wound infection.

Figures

Fig. 1
Fig. 1
Participant Flow Diagram
Fig. 2
Fig. 2
EQ-5D over time. Open-No Infection coincides with Closed-No Infection. Mean EQ-5D was used as a measure of health outcome over 12 months post-surgery

References

    1. Joshipura MK, Shah HS, Patel PR, Divatia PA, Desai PM. Trauma care systems in India. Injury. 2003;34(9):686–692. doi: 10.1016/S0020-1383(03)00163-3.
    1. Bhandari M, Guyatt G, Tornetta P, 3rd, Schemitsch E, Swiontkowski M, Sanders D, et al. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008;9:91. doi: 10.1186/1471-2474-9-91.
    1. 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;36(4):233–235. doi: 10.1258/004947506778604689.
    1. SooHoo NF, Krenek L, Eagan MJ, Gurbani B, Ko CY, Zingmond DS. Complication rates following open reduction and internal fixation of ankle fractures. J Bone Joint Surg Am. 2009;91(5):1042–1049. doi: 10.2106/JBJS.H.00653.
    1. Steiner AK, Kotisso B. Open fractures and internal fixation in a major African hospital. Injury. 1996;27(9):625–630. doi: 10.1016/S0020-1383(96)00107-6.
    1. Carragee EJ, Csongradi JJ, Bleck EE. Early complications in the operative treatment of ankle fractures. Influence of delay before operation. J Bone Joint Surg Br. 1991;73(1):79–82.
    1. INORMUS Investigators Operationalizing an orthopaedic research plan in the Decade of Action for Road Safety: the INternational ORthopaedic MUlticenter Study in Fracture Care. J Orthop Trauma. 2014;28(Suppl 1):S29.
    1. Daabiss M. American Society of Anaesthesiologists physical status classification. Indian J Anaesth. 2011;55(2):111–115. doi: 10.4103/0019-5049.79879.
    1. CDC. Surgical Site Infection (SSI) Event. Procedure-associated Module. 2015:9-1 - 9-26.
    1. Bhandari M, Guyatt G, Tornetta P, 3rd, Schemitsch EH, Swiontkowski M, Sanders D, et al. Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008;90(12):2567–2578. doi: 10.2106/JBJS.G.01694.
    1. The Flow Investigators A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds. N Engl J Med. 2015;373:2629–2641. doi: 10.1056/NEJMoa1508502.
    1. Goel S, Singh A, Tiwari Y. Arrival Time Pattern And Waiting Time Distribution Of Patients In The Emergency Outpatient Department Of A Tertiary Level Health Care Institution Of North India. J Emerg Trauma Shock. 2014;7(3):160. doi: 10.4103/0974-2700.136855.
    1. Hauser CJ, Adams CA, Jr, Eachempati SR. Surgical Infection Society guideline: prophylactic antibiotic use in open fractures: an evidence-based guideline. Surg Infect (Larchmt) 2006;7(4):379–405. doi: 10.1089/sur.2006.7.379.
    1. Rodriguez L, Jung HS, Goulet JA, Cicalo A, Machado-Aranda DA, Napolitano LM. Evidence-based protocol for prophylactic antibiotics in open fractures: improved antibiotic stewardship with no increase in infection rates. J Trauma Acute Care Surg. 2014;77(3):400–407. doi: 10.1097/TA.0000000000000398.
    1. Bhandari M, Guyatt GH, Swiontkowski MF, Schemitsch EH. Treatment of open fractures of the shaft of the tibia. J Bone Joint Surg Br. 2001;83(1):62–68. doi: 10.1302/0301-620X.83B1.10986.
    1. Chang Y, Kennedy S, Bhandari M, Lopes L, de C´assia Bergamaschi C, de Oliveira e Silva M, et al. Effects of Antibiotic Prophylaxis in Patients with Open Fracture of the Extremities. JBJS Reviews. 2015;5(6):e2.
    1. Young S, Lie SA, Hallan G, Zirkle LG, Engesaeter LB, Havelin LI. Risk factors for infection after 46,113 intramedullary nail operations in low- and middle-income countries. World J Surg. 2013;37(2):349–355. doi: 10.1007/s00268-012-1817-4.
    1. Agrawal AC, Jain S, Jain RK, Raza HK. Pathogenic bacteria in an orthopaedic hospital in India. J Infect Dev Ctries. 2008;2(2):120–123. doi: 10.3855/T2.2.120.
    1. Leaper D, Fry D, Assadian O. Perspectives in prevention and treatment of surgical site infection - a narrative review of the literature. Wounds. 2013;25(11):313–323.
    1. Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, et al. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014;59(2):e10–52. doi: 10.1093/cid/ciu296.
    1. Whitehouse JD, Friedman ND, Kirkland KB, Richardson WJ, Sexton DJ. The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality of life, excess length of stay, and extra cost. Infect Control Hosp Epidemiol. 2002;23(4):183–189. doi: 10.1086/502033.

Source: PubMed

3
Sottoscrivi