Trial Outcomes & Findings for Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures (NCT NCT03148067)
NCT ID: NCT03148067
Last Updated: 2019-06-20
Results Overview
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
COMPLETED
225 participants
one year after surgery
2019-06-20
Participant Flow
Participant milestones
| Measure |
Patients
221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up
Intramedullary nailing for fracture fixation
|
|---|---|
|
Overall Study
STARTED
|
225
|
|
Overall Study
COMPLETED
|
221
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Patients
221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up
Intramedullary nailing for fracture fixation
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients
n=221 Participants
Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation
Intramedullary nailing for fracture fixation
|
|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 15.2 • n=221 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=221 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=221 Participants
|
|
Region of Enrollment
Brazil
|
221 participants
n=221 Participants
|
PRIMARY outcome
Timeframe: one year after surgeryPopulation: 221 patients included in the study completed the planned follow up period. In total, 26 cases of infection were observed, with an incidence of 11.8%.
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
Outcome measures
| Measure |
Patients
n=221 Participants
221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up. In total, 26 cases of infection were observed after 12 months of follow-up, with an incidence of 11.8%.
|
|---|---|
|
Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures
Patients with infection
|
26 Participants
|
|
Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures
Patients without infection
|
195 Participants
|
SECONDARY outcome
Timeframe: one year after surgeryPopulation: Previous use of external fixations (OR 2.53) and need for soft tissue reconstruction (OR 10.94) were associated to surgical site infections after intramedular nailing
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.
Outcome measures
| Measure |
Patients
n=221 Participants
221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up. In total, 26 cases of infection were observed after 12 months of follow-up, with an incidence of 11.8%.
|
|---|---|
|
Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing
Previous use of external fixation
|
2.53 odds ratio
Interval 0.98 to 6.56
|
|
Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing
Need for soft tissue reconstruction
|
10.94 odds ratio
Interval 3.07 to 38.92
|
Adverse Events
Patients
Serious adverse events
| Measure |
Patients
n=221 participants at risk
221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up
Intramedullary nailing for fracture fixation
|
|---|---|
|
Infections and infestations
Surgical site infection
|
11.8%
26/221 • Number of events 26 • 18 months
26 cases of infection were observed after 12 months of follow-up. One patient died from infection.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place