- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03148067
Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Prospective Study on the Incidence and Risk Factors for the Occurrence of Surgical Site Infection After Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures
Study Overview
Status
Intervention / Treatment
Detailed Description
Diaphyseal femoral and tibial fractures are a important challenge faced by the orthopedic surgeon, due to their high incidence and high social and economic impact. Currently, the observed increases in the rates of injuries secondary to traffic, work and firearms-related accidents, and also those related to sports practice, have led to significant growth of the incidence of these fractures, especially among young and economically active individuals .
Although standardized criteria for indications of conservative treatment exist, surgery is often recommended due to its better functional results and shorter rehabilitation period. Intramedullary nailing (IMN) was introduced by Küntscher in 1939 and remains the method of choice for treating these fractures, both closed and open ones, especially because the surgical technique is considered to be simple, standardized and replicable; does not cause major soft tissue damage and allows early loading. This technique is associated with a higher consolidation rate and lower incidence of complications, among which infections are included.
Surgical site infection (SSI) after internal fracture fixation is considered to be a severe, hard-to-treat complication, and it is important to remember that the presence of the implant itself favors bacterial invasion and alters local immunity, thus hampering the action of granulocytes. In addition, injury to the soft tissues adjacent to the fracture focus also hampers this immunity and favors occurrence of infections.
Although complications are less frequent than in other internal fracture fixation methods, they can occur during the postoperative period, relating to the use of IMN, and these may include SSI. Its occurrence significantly increases recovery time and treatment costs, and it compromises the long-term functional results and rehabilitation.
SSIs, including those related to IMN, are defined internationally in accordance with the criteria established in the United States (USA) by the National Healthcare Safety Network (NHSN), an agency belonging to the Centers for Disease Control and Prevention (CDC). 8 This body is responsible for healthcare-related infection surveillance actions in that country. In Brazil, as in other countries, adaptations made by the local health and epidemiological surveillance authorities are followed.
In January 2015, the NHSN made available a document with new definitions of SSI, which came into force in the USA from that moment onwards, with important changes. The period for defining infections relating to fracture fixation procedures, regardless of the type of synthesis material used, became only 90 days, instead of one year from the data of the surgery. For better evaluation, however, for the present study, the surveillance period remains one year for defining SSIs relating to IMN.
Different incidences of SSI after fixation of lower-limb fractures through IMN have been reported in the literature. Most of these have come from retrospective studies and as part of the description of series of cases of patients who underwent this procedure, with little detail about the criteria used for defining and searching for SSI cases. Only two prospective studies have so far reported the occurrence of this complication: these studies were not specifically designed for evaluating SSI and only describe its occurrence superficially, among other complications . Until recently, only Gaebler et al., in 2000, had described this complication with greater methodological rigor. In 2015, however, because of the gap in knowledge that existed, three authors published the results from retrospective studies that had been specifically designed for evaluating SSIs relating to IMN for correcting lower-limb fractures. Despite this recent interest in this subject among researchers, there continue to be no prospective studies specifically designed for investigating the incidence of this complication, or its risk factors. In Latin America, in particular, there are no studies of any kind evaluating the incidence of SSI after fixation of lower-limb fractures using IMN.
Risk factors for occurrences of surgical site infections are generally divided into those relating to the host, the surgical environment and the microbiota. For occurrences of SSI after fracture fixation procedures, the following are considered also to be risk factors: degree of energy of the associated trauma, degree of injury of the adjacent soft tissues, degree of local contamination, duration of osteosynthesis surgery and immunological status of the patient.
However, specifically with regard to risk factors relating to occurrences of SSI after fixation of lower-limb fractures through IMN, information is scarce, given that the majority of the studies that analyzed the incidence of this complication did not allow for analysis of the risk factors relating to their occurrence. Until 2015, only Gaebler et al. had published results from an analysis on these risk factors. They concluded from their retrospective study that the risk of acquiring SSI after implantation of IMNs was 22.4 times higher among patients with Gustilo III open fractures than among patients with other types of fractures. However, these authors did not evaluate the importance of other factors that are considered to be associated with occurrences of SSI after fracture fixation.
Because of the lack of information on this important subject, in 2015 three authors published results from retrospective investigations that enabled a few conclusions. Galvin et al., in their study on closed tibial fractures in American soldiers, found higher incidence of SSI after IMN in patients who presented clinical instability during the initial care, although this difference was not statistically significant.
In turn, Metsemakers et al. concluded, after an initial univariate analysis, that previous use of external fixators, occurrences of open fractures and the severity of exposure according to Gustilo-Anderson would be factors associated with occurrences of SSI, as also would greater time intervals between the fracture and its fixation through IMN. It needs to be highlighted that these authors did not define the time interval above which the risk of infection would be greater. After multiple logistic regression analysis, however, only previous external fixation remained as a factor associated with occurrence of SSI after internal fixation of the fracture with IMN. In the study conducted by Roussignol et al., only the severity of the open fracture according to the Gustilo-Anderson classification had a statistically significant correlation with occurrences of infection. Other variables, including the severity according to the AO classification, previous external fixation, and time interval between fracture and its internal fixation did not present correlations with increased incidence of SSI associated with IMN.
It needs to be emphasized that none of the studies cited that presented information on the factors associated with occurrences of SSI after fracture fixation through IMN were prospective. This shows that the medical literature still lacks information obtained using greater methodological rigor.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Closed and open diaphyseal femoral and tibial fractures treated through IMN;
- Age: 16 years or older
- The patient or a person legally responsible for the patient should sign the free and informed consent statement (FICS) in order to take part in the study.
Exclusion Criteria:
- No exclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures
Time Frame: one year after surgery
|
Patients who present signs of infection in the region of the surgery under evaluation or who describe alterations compatible with SSI, or whose records mention signs or symptoms compatible with the definitions of SSI, are considered to be cases with evolution to infection.
Patients included in the study who, during routine or emergency care present a condition (according to the researchers' evaluation) suggestive of a SSI associated with intramedullary nailing are considered to be cases of infection
|
one year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing
Time Frame: one year after surgery
|
Patient-related factors: age; gender; body mass index; duration of preoperative hospitalization; infection in other foci; presence of immunosuppressive conditions; physical status classification according to ASA; occurrences of multiple trauma and ISS score; injury etiology; exposure time (for open fractures); AO fracture classification; soft-tissue injury classification; Gustilo-Anderson open fracture classification; stay at other hospital before transference; use of external fixation; previous surgical manipulation and use of blood products.
Factors relating to the surgery: wound classification according to potential for contamination; surgery length; hair removal; antibiotic prophylaxis or therapy; use of drains; patient temperature and oxygenation; type of nail used (anterograde or retrograde); reaming; primary closure; necessity for a skin-muscle flap and use of negative-pressure wound therapy.
Microbiota-related factors: evaluation of colonization by S. aureus and A. baumannii.
|
one year after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ana Lucia M Lima, MD, PhD, Assistant Professor
Publications and helpful links
General Publications
- Gustilo RB, Mendoza RM, Williams DN. Problems in the management of type III (severe) open fractures: a new classification of type III open fractures. J Trauma. 1984 Aug;24(8):742-6. doi: 10.1097/00005373-198408000-00009.
- 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 Feb;37(2):349-55. doi: 10.1007/s00268-012-1817-4.
- Ozdemir B, Akesen B, Demirag B, Bilgen MS, Durak K. Long-term outcome of unreamed intramedullary nails in femur diaphyseal fractures. Ulus Travma Acil Cerrahi Derg. 2012 Mar;18(2):147-52. doi: 10.5505/tjtes.2012.19970.
- Pfeifer R, Sellei R, Pape HC. The biology of intramedullary reaming. Injury. 2010 Nov;41 Suppl 2:S4-8. doi: 10.1016/S0020-1383(10)70002-4.
- Petrisor B, Anderson S, Court-Brown CM. Infection after reamed intramedullary nailing of the tibia: a case series review. J Orthop Trauma. 2005 Aug;19(7):437-41. doi: 10.1097/01.bot.0000161542.93624.8d.
- Ricci WM, Gallagher B, Haidukewych GJ. Intramedullary nailing of femoral shaft fractures: current concepts. J Am Acad Orthop Surg. 2009 May;17(5):296-305. doi: 10.5435/00124635-200905000-00004.
- Schmidt AH, Swiontkowski MF. Pathophysiology of infections after internal fixation of fractures. J Am Acad Orthop Surg. 2000 Sep-Oct;8(5):285-91. doi: 10.5435/00124635-200009000-00002.
- Horan TC, Gaynes RP. Surveillance of nosocomial infections. In:Hospital epidemiology and infection control, 3rd ed., Mayhall CG, editor. Philadelphia:Lippincott Williams & Wilkins,2004:1659-702
- Centers for Disease Control and Prevention. Surgical Site Infection (SSI) Event. Atlanta, EUA: 2016. Available in: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
- Court-Brown CM, Christie J, McQueen MM. Closed intramedullary tibial nailing. Its use in closed and type I open fractures. J Bone Joint Surg Br. 1990 Jul;72(4):605-11. doi: 10.1302/0301-620X.72B4.2380211.
- Alho A, Ekeland A, Stromsoe K, Folleras G, Thoresen BO. Locked intramedullary nailing for displaced tibial shaft fractures. J Bone Joint Surg Br. 1990 Sep;72(5):805-9. doi: 10.1302/0301-620X.72B5.2211761. Erratum In: J Bone Joint Surg Br 1991 Jan;73(1):181.
- Gaebler C, Berger U, Schandelmaier P, Greitbauer M, Schauwecker HH, Applegate B, Zych G, Vecsei V. Rates and odds ratios for complications in closed and open tibial fractures treated with unreamed, small diameter tibial nails: a multicenter analysis of 467 cases. J Orthop Trauma. 2001 Aug;15(6):415-23. doi: 10.1097/00005131-200108000-00006.
- Galvin JW, Dannenbaum JH 4th, Tubb CC, Poepping TP, Grassbaugh JA, Arrington ED. Infection Rate of Intramedullary Nailing in Closed Fractures of the Femoral Diaphysis After Temporizing External Fixation in an Austere Environment. J Orthop Trauma. 2015 Sep;29(9):e316-20. doi: 10.1097/BOT.0000000000000327.
- Metsemakers WJ, Handojo K, Reynders P, Sermon A, Vanderschot P, Nijs S. Individual risk factors for deep infection and compromised fracture healing after intramedullary nailing of tibial shaft fractures: a single centre experience of 480 patients. Injury. 2015 Apr;46(4):740-5. doi: 10.1016/j.injury.2014.12.018. Epub 2014 Dec 27.
- Roussignol X, Sigonney G, Potage D, Etienne M, Duparc F, Dujardin F. Secondary nailing after external fixation for tibial shaft fracture: risk factors for union and infection. A 55 case series. Orthop Traumatol Surg Res. 2015 Feb;101(1):89-92. doi: 10.1016/j.otsr.2014.10.017. Epub 2015 Jan 13.
- Winquist RA, Hansen ST Jr, Clawson DK. Closed intramedullary nailing of femoral fractures. A report of five hundred and twenty cases. J Bone Joint Surg Am. 1984 Apr;66(4):529-39.
- Court-Brown CM, McQueen MM, Quaba AA, Christie J. Locked intramedullary nailing of open tibial fractures. J Bone Joint Surg Br. 1991 Nov;73(6):959-64. doi: 10.1302/0301-620X.73B6.1955445.
- Court-Brown CM, Keating JF, McQueen MM. Infection after intramedullary nailing of the tibia. Incidence and protocol for management. J Bone Joint Surg Br. 1992 Sep;74(5):770-4. doi: 10.1302/0301-620X.74B5.1527132.
- Keating JF, Blachut PA, O'Brien PJ, Court-Brown CM. Reamed nailing of Gustilo grade-IIIB tibial fractures. J Bone Joint Surg Br. 2000 Nov;82(8):1113-6. doi: 10.1302/0301-620x.82b8.10566.
- Court-Brown CM. Reamed intramedullary tibial nailing: an overview and analysis of 1106 cases. J Orthop Trauma. 2004 Feb;18(2):96-101. doi: 10.1097/00005131-200402000-00007. No abstract available.
- Halvorson JJ, Barnett M, Jackson B, Birkedal JP. Risk of septic knee following retrograde intramedullary nailing of open and closed femur fractures. J Orthop Surg Res. 2012 Feb 17;7:7. doi: 10.1186/1749-799X-7-7.
- Sie E, Kacou A, Traore A, Sery B, Lambin Y. Primary unreamed and unlocked intramedullary nailing of femoral shaft fractures. Malays Orthop J. 2012 Nov;6(3):13-7. doi: 10.5704/MOJ.1207.014.
- Salem KH. Unreamed intramedullary nailing in distal tibial fractures. Int Orthop. 2013 Oct;37(10):2009-15. doi: 10.1007/s00264-013-1998-y. Epub 2013 Jul 28.
- AO Foundation. AO/OTA Fracture and dislocation classification. Davos, Suíça: 2014. Available in: https://www.aofoundation.org/Structure/resource/AO-OTA-Fracture-Dislocation-Classification/Pages/AO-OTA-Fracture-Dislocation-Classification-Long-Bones.aspx
- Gustilo RB, Anderson JT. Prevention of infection in the treatment of one thousand and twenty-five open fractures of long bones: retrospective and prospective analyses. J Bone Joint Surg Am. 1976 Jun;58(4):453-8.
- Maragakis LL, Perl TM. Basics of surgical site infection surveillance and prevention. In: Practical Healthcare Epidemiology, 3rd ed., Lautenbach E, Woeltje KF, Malani PN, editor. Chicago: The University of Chicago Press, 2010:173-185
- Oliveira PR, Carvalho VC, da Silva Felix C, de Paula AP, Santos-Silva J, Lima AL. The incidence and microbiological profile of surgical site infections following internal fixation of closed and open fractures. Rev Bras Ortop. 2016 Feb 2;51(4):396-9. doi: 10.1016/j.rboe.2015.09.012. eCollection 2016 Jul-Aug.
- Silva AGP, Silva FBA, Godoy-Santos AL, Luzo CAM, Sakaki MH, Zumiotti AV. Infecção pós-estabilização intramedular das fraturas diafisárias dos membros inferiores: Protocolo de tratamento. Acta Ortop Bras 2008;16:266-9
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10075 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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