CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
Intramedullary nailing for fracture fixationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03148067
NCT03148067N/ACompleted

Prospective Study on the Incidence and Risk Factors for the Occurrence of Surgical Site Infection After Intramedullary Nailing of Diaphyseal Femoral and Tibial Fractures

University of Sao Paulo·observational·Posted May 10, 2017·Updated Jun 20, 2019

In Brief

An observational study evaluating Intramedullary nailing for fracture fixation for Fracture Fixation, Intramedullary and Surgical Wound Infection. Completed, enrolled 225 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
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Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartSep 15, 2015
Primary CompletionApr 3, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.1 years ago

Interventions

Intramedullary nailing for fracture fixationprocedure