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N/A N=225

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

Fracture Fixation, Intramedullary · Surgical Wound Infection

Enrolled (actual)
225
Serious AEs
11.8%
Results posted
Jun 2019
Primary outcome: Primary: Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures — 26; 195 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Intramedullary nailing for fracture fixation (Procedure)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
University of Sao Paulo
Primary completion
Apr 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures
26; 195
SECONDARY
Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing
2.53; 10.94

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03148067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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