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

Recruitment status

COMPLETED

Target enrollment

225 participants

Primary outcome timeframe

one year after surgery

Results posted on

2019-06-20

Participant Flow

Participant milestones

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

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

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 surgery

Population: 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

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 surgery

Population: 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

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 events: 26 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

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

Physician

University of Sao Paulo

Phone: 551126616900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place