Clinical trial NCT03343990: Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure
Official title: Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure Post Open Heart Surgery in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sternotomy Closure,Open Heart Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient above 16 years undergoing open heart surgery with sternotomy

Brief summary: Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients

Detailed description: Comparison between interlocking multi-twisted wires and Eight figure of sternum closure post open heart surgery in egptian patients

Midline sternotomy, first described by Milton in 1887 \[4,7,8\] remains the most popular technique of cardiac exposure because of its quick and easy performance, excellent access to the heart and great vessels. Effective prevention methods for disruption and infection of median sternotomy continue to be debated. The most important factor in preventing PSWC is a stable sternal approximation, as bony union depends on adequate reduction and immobilization of the stern costal junctions. Strict adherence of preoperative aseptic technique is crucial. Careful attention to homeostasis and meticulous surgical technique remain the mainstays of prevention and must include precise sternal alignment and stable closure. While biomechanical studies appear to be valid, their general value is limited Different sternal closure techniques

1. Trans-sternal/peristernal wiring
2. Bilateral and longitudinal parasternal running wires (described by Robicsek)
3. Double wires
4. Steel band
5. Figure of eight The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture .
6. Interlocking multi-twisted wires One of recent way in closure of sternal gives more stabilization. At least 6 wires have to be passed. The wires should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other the wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends buried

6- Alternative techniques

Techniques utilizing lateral sternal support are first-line options in preventing SD and wound infections. The need to provide lateral reinforcement of the sternum has led to the development of several techniques, such as A-the use of lateral staples and lateral plates B-H-shaped titanium plates C- Reinforced sternal closure system D-thermo reactive clips E- Rigid plate fixation change

The purpose of this report was to analyze (I) the efficacy of most used ways in sternal closure in our center ( interlocking multi-twisted wires and Eight figure )for the prevention of Post sternal wound complication in adult egyptian patients and find the way more efficient in sternal closure.

Eligibility criteria: Inclusion Criteria:

1. Adult patient above 16 years undergoing open heart surgery with sternotomy
2. Patient is willing to comply with all follow-up visits.
3. Willing and able to provide written informed consent and comply with study requirements

Exclusion Criteria:

1. Pediatric patients below 16 years
2. Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.

Primary outcomes:
measure: Healing of the sternum
timeFrame: 60 days
Secondary outcomes:
measure: rate of wound infection
timeFrame: 30 days
measure: mobilization
timeFrame: 45 days
measure: Time of procedure
timeFrame: 45 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
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citation: Noyez L, van Druten JA, Mulder J, Schroen AM, Skotnicki SH, Brouwer RM. Sternal wound complications after primary isolated myocardial revascularization: the importance of the post-operative variables. Eur J Cardiothorac Surg. 2001 Apr;19(4):471-6. doi: 10.1016/s1010-7940(01)00610-8.
citation: [11] Prakash.P.Punjabi Essentials_of_Operative cardiac surgery page 62 chest closure