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

NCT03343990 | Unknown DMC

• 1 other identifier: sternal closure
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sternotomy Closure,Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Healing of the sternum

  Duration of complete healing of the sternum :By 1. Radiological (chest x-ray ant-post view and lat view in first 6 weeks post-operative 2. Clinical examination in first 6 weeks post operative

  60 days

Secondary Outcomes (3)

• rate of wound infection

  30 days

• mobilization

  45 days

• Time of procedure

  45 days

Study Arms (2)

group A

Interlocking multi-twisted wires techniqe in sternal closure

Procedure: Interlocking multi-twisted wires in sternal closure; Procedure: Eight Figure techniqe in sternal closure

group B

Eight Figure techniqe in sternal closure

Procedure: Interlocking multi-twisted wires in sternal closure; Procedure: Eight Figure techniqe in sternal closure

Interventions

Interlocking multi-twisted wires in sternal closure PROCEDURE

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

Also known as: prakash p.punjabi

group A; group B

Eight Figure techniqe in sternal closure PROCEDURE

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

group A; group B

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patient above 16 years undergoing open heart surgery with sternotomy

You may qualify if:

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

You may not qualify if:

• Pediatric patients below 16 years
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71621, Egypt

RECRUITING

Related Publications (8)

• 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. doi: 10.1016/j.jtcvs.2006.04.037.

  PMID: 16935107 RESULT

• 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. doi: 10.1016/j.ejcts.2004.04.038.

  PMID: 15296898 RESULT

• 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. doi: 10.1016/s0022-5223(03)00945-0.

  PMID: 14666006 RESULT

• 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. doi: 10.1016/s0003-4975(03)01468-1.

  PMID: 14726062 RESULT

• Robicsek F, Fokin A, Cook J, Bhatia D. Sternal instability after midline sternotomy. Thorac Cardiovasc Surg. 2000 Feb;48(1):1-8. doi: 10.1055/s-2000-9945.

  PMID: 10757149 RESULT

• 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. doi: 10.1510/icvts.2007.164004. Epub 2007 Sep 20.

  PMID: 17884847 RESULT

• 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.

  PMID: 11306315 RESULT

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

  RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sternal closure

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2019
• Primary Completion: March 29, 2019
• Study Completion: December 30, 2020
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

EG (1)