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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000973516
Acronym
PiCT – Pioneer Cabling Trial
Enrollment
279
Registered
2015-09-17
Start date
2013-07-01
Completion date
2014-12-22
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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-designed tool to tighten the cables and achieve equal distribution of forces and prevent over-tightening.

Sponsors

Mr Chris Merry
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Our inclusion criteria were any patient of 18 years of age or older, presenting for first time elective, urgent or emergent cardiac surgery via full sternotomy and being able to provide informed consent.

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026