Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures

NCT03148067 | Completed Results

• 1 other identifier: 10075
• Study Type: observational
• Target: 225
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diaphyseal femoral and tibial fractures are in the spotlight within the traumatology-orthopedics scenario. Intramedullary nailing (IMN) remains the method of choice for treating these fractures, both open and closed ones. Occurrences of surgical site infection (SSI) related to this type of osteosynthesis are a challenge for all the professionals involved in patient healthcare. The reported incidence of SSI after IMN ranges from 0.9 to 17.5%. The majority of the data comes from retrospective studies and as part of case series descriptions, with little detail about the criteria used for defining and searching for cases of infection. Regarding the potential risk factors for this complication, previous use of external fixators, occurrence of open fractures and the severity of exposure according to the Gustilo-Anderson classification were indicated in a few retrospective studies as being possibly related to this complication. The objectives of the present observational cohort study are: 1. To determine the incidence of SSI related to IMN for fixation of diaphyseal femoral and tibial fractures in patients treated in a university traumatology and orthopedics reference hospital in São Paulo, Brazil; 2. To evaluate the risk factors related to the occurrence of this type of infection.

Conditions

Fracture Fixation, Intramedullary; Surgical Wound Infection

Keywords

Risk Factors; Incidence; Epidemiology

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures

  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 Outcomes (1)

• Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing

  one year after surgery

Study Arms (1)

Patients

Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation

Procedure: Intramedullary nailing for fracture fixation

Interventions

Intramedullary nailing for fracture fixation PROCEDURE

Patients

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were included in the research after the surgical plan for intramedullary nailing for fixation of their fractures has been defined. This inclusion could occur up to 72 hours after the surgical procedure. If a patient presented more than one diaphyseal femoral or tibial fracture that could be potentially included in the study, only the first surgically corrected fracture were considered for analysis in the study.

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (28)

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  BACKGROUND

• 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

  BACKGROUND

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  PMID: 14743029 BACKGROUND

• 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.

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  BACKGROUND

• 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.

  PMID: 773941 BACKGROUND

• 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.

  PMID: 6471139 BACKGROUND

• 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

  BACKGROUND

• 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.

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• 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

  BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Fracture Fixation, Intramedullary; Fracture Fixation

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Limitations and Caveats

Hyperglicemia was not measured.

Results Point of Contact

• Title: Physician
• Organization: University of Sao Paulo

priscila.rosalba@hc.fm.usp.br

551126616900

Study Officials

• Ana Lucia M Lima, MD, PhD

  Assistant Professor

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: September 15, 2015
• Primary Completion: April 3, 2017
• Study Completion: April 3, 2017
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share