CompletedPhase 4ACTRN12615000973516

A randomised controlled trial comparing sternal wires with sternal cabling for prevention of deep sternal wound infection in patients undergoing cardiac surgery

A Randomised Controlled Trial of Sternal Closure with Sternal Wires or Sternal Cables for prevention of Deep Sternal Wound Infection in patients undergoing cardiac surgery


Sponsor

Mr Chris Merry

Enrollment

300 participants

Start Date

Jul 1, 2013

Study Type

Interventional

Conditions

Summary

Background Deep sternal wound infection is a devastating complication of cardiac surgery. In the current era of increasing patient co-morbidity, newer techniques must be evaluated in attempts to reduce the rates of deep sternal wound infection. Methods A randomised controlled trial comparing sternal closure with traditional sternal wires in figure-8 formation with the Pioneer cabling system [Registered Trademark] from Medigroup after adult cardiac surgery was performed. Results 273 patients were enrolled with 137 and 135 patients randomised to sternal wires and cables group, respectively. Baseline characteristics between the two groups were well balanced. Deep sternal wound infection occurred in 0.7% of patients in the wires group and 3.7% of patients in the cables group (absolute risk difference = -3.0%, 95% confidence interval: -7.7% to 0.9%; p=0.12). Patients in the cables group were extubated slightly earlier than the patients in the sternal wires group postoperatively (9.7 vs. 12.8 hours; p=0.03). There was, however, no significant difference in hospital and follow-up pain scores or analgaesia requirements. Conclusions The Pioneer sternal cabling system appears to facilitate early extubation after adult cardiac surgery, but it does not reduce the rate of deep sternal infection.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Exclusion Criteria8

  • Redo Sternotomy
  • Salvage surgery – CPR en route to theatre
  • Cardiac transplant
  • Left ventricular assist device insertion
  • Pregnant women
  • Patients with cognitive impairment
  • Intravenous drug users
  • Patients on opiate analgaesia pre-op

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Interventions

The Pioneer Sternal Cabling system is used to approximate the cut edges of the sternum after median sternotomy. It uses braided titanium cables in figure-eight formation, tightened with a specifically

The Pioneer Sternal Cabling system is used to approximate the cut edges of the sternum after median sternotomy. It uses braided titanium cables in figure-eight formation, tightened with a specifically-designed tool to tighten the cables and achieve equal distribution of forces and prevent over-tightening.


Locations(1)

Royal Perth Hospital - Perth

WA, Australia

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ACTRN12615000973516