Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure

Sternotomy Closure,Open Heart Surgery Clinical Trial

Official title:

Comparison Between Interlocking Multi-twisted Wires and Eight Figure of Sternum Closure Post Open Heart Surgery in Egyptian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03343990
• Other study ID #: sternal closure
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sternotomy Closure,Open Heart Surgery

Intervention

Procedure:
• Interlocking multi-twisted wires in sternal closure
One of many ways in cloure of sternal give more stabilization. At least 6 wires have to be passed. The wirs 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 of the are burried
• Eight Figure techniqe in sternal closure
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

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

[11] Prakash.P.Punjabi Essentials_of_Operative cardiac surgery page 62 chest closure

Bottio T, Rizzoli G, Vida V, Casarotto D, Gerosa G. Double crisscross sternal wiring and chest wound infections: a prospective randomized study. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1352-6. — View Citation

Karra R, McDermott L, Connelly S, Smith P, Sexton DJ, Kaye KS. Risk factors for 1-year mortality after postoperative mediastinitis. J Thorac Cardiovasc Surg. 2006 Sep;132(3):537-43. — View Citation

Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. — View Citation

Noyez L, van Druten JA, Mulder J, Schroën 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. — View Citation

Robicsek F, Fokin A, Cook J, Bhatia D. Sternal instability after midline sternotomy. Thorac Cardiovasc Surg. 2000 Feb;48(1):1-8. — View Citation

Schimmer C, Sommer SP, Bensch M, Leyh R. Primary treatment of deep sternal wound infection after cardiac surgery: a survey of German heart surgery centers. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):708-11. Epub 2007 Sep 20. — View Citation

Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of the sternum	Duration of complete healing of the sternum :By; Radiological (chest x-ray ant-post view and lat view in first 6 weeks post-operative; Clinical examination in first 6 weeks post operative	60 days
Secondary	rate of wound infection	way less liable to infect wound either skin infection or wound dehiscence	30 days
Secondary	mobilization	Early mobilization after surgery till returning to normal movement including freely arm movement	45 days
Secondary	Time of procedure	time taken by each way in sternal closure	45 days