Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

Unstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a n...

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Bibliographic Details
Published in:Journal of cardiothoracic surgery 2014-06, Vol.9 (1), p.97-97, Article 97
Main Authors: Boustany, Ashley N, Ghareeb, Paul, Lee, Kee
Format: Article
Language:English
Subjects:
Analysis
Bone Wires
Clinical trials
Comparative analysis
Economic aspects
Elective Surgical Procedures - adverse effects
Equipment Design
Female
Follow-Up Studies
Humans
Male
Medical care, Cost of
Medical research
Medicine, Experimental
Middle Aged
Pilot Projects
Prospective Studies
Single-Blind Method
Sternotomy - adverse effects
Sternum - surgery
Surgical Wound Dehiscence - etiology
Surgical Wound Dehiscence - surgery
Treatment Outcome
Wound Closure Techniques - instrumentation
Wound Healing
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Summary:Unstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple, intuitive, and inexpensive alternative for primary sternal repair following open heart surgery. Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire. We present our initial experience in a prospective, randomized, single blinded pilot study utilizing this FDA approved system. Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage. All surgeries were performed by a single board certified cardiothoracic surgeon. Data collected included: Age, BMI, pump time, off pump to surgical stop time, length of hospital stay after surgery, cost from time of surgery to discharge, and pain on a visual analog pain scale on the day of discharge, day 30, and day 60. The groups were well matched. Patients receiving the Figure 8 FlatWire (33) had a reduction in length of stay compared to patients receiving steel wire circlage (30), but it was not statistically significant (6.8 vs. 7.8 days respectively, p 
ISSN:1749-8090
1749-8090
DOI:10.1186/1749-8090-9-97