ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000852550

Ethics application status

Approved

Date submitted

29/07/2015

Date registered

17/08/2015

Date last updated

14/09/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of two different techniques to close the sternum following cardiac surgery

Scientific title

Comparison of sternal closure methods measuring pain and sternal stability following median sternotomy incision for cardiothoracic surgery

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

sternal fixation following sternotomy

Condition category

Condition code

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The aim of this research is to compare the outcomes in cardiac surgery patients who have sternal fixation using stainless steel wires (current practice at The Alfred) with patients who have sternal fixation using Zipfix cable ties (intervention).

Applying the Zipfix cable ties involves using 5 biocompatible cable ties looped around both halves of the sternum using a removable needle, then they are tightened to pull the sternal halves back together. The remaining length of the cable tie is then cut using a specialized cutting device.

Cardiac surgeons will perform the sternal closure on patients using the Zipfix system.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Rehabilitation

Comparator / control treatment

Cardiac surgery patients who have sternal fixation using stainless steel wires. This is standard care at The Alfred following cardiac surgery.

Control group

Active

Outcomes

Primary outcome [1]

Primary outcome - postoperative pain
Level of postoperative pain will be assessed using the validated pain visual analogue scale.

Timepoint [1]

Day 1, Day 3, at discharge and 4 weeks post median sternotomy

Secondary outcome [1]

Sternal mobility in the postoperative period using the sternal instability scale.

Timepoint [1]

Sternal mobility will be assessed at 4 weeks following median sternotomy using ultrasound.

Eligibility

Key inclusion criteria

The inclusion criteria are:
* undergoing an operation involving median sternotomy
* age greater than 18 years
* competence to provide informed consent
* ability to undertake the visual testing and complete questionnaires
* redo sternotomy will be included

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

The exclusion criteria are:
* heart transplant and VAD patients

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The 120 patients will be recruited in chronological fashion. Only on the day of the operation will they be randomized to either group. using sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer program will be used to generate the randomization sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Using a continuous definition of pain from the visual analog pain scale, a reduction of pain by 50% between groups is considered to be clinically significant. From a previous study involving massage in cardiac surgery patients with a mean pain score of 2.6 and delta value of 1.20, in order to detect a 50% reduction in pain with alpha level 0.05 and power 0.8 requires 54 patients. With a drop out rate of 10%, this would be 60 patients per group.

Therefore 60 patients per group would be adequately powered to detect a clinically significant difference in outcome measures. This will require enrollment of 120 patients in the study.

Visual analog pain scores will be analysed between groups comparing means between the two groups (t-tests).

Sternal instability will be analysed by a simple chi square analysis comparing proportions for the three categories of instability.

A multivariate analysis will be undertaken to account for confounding variables (ANCOVA).

The level of statistical significance will be set at a p-value <0.05.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/09/2015

Actual

1/02/2016

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Alfred Health

Address

55 Commercial Road
Melbourne 3004
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Human Research Ethics Committee (EC00315)

Ethics committee address [1]

The Alfred Hospital
55 Commercial Rd.
Melbourne, 3004
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2015

Approval date [1]

21/10/2015

Ethics approval number [1]

Summary

Brief summary

Current standard practice at The Alfred Hospital involves closing the sternum following cardiac surgery with stainless steel wires.  Alternative sternal closing techniques also exist, however to date closure of the sternum using stainless steel wires remains the standard technique because of its low cost.  The cable tie method of sternal closure however is a widely used sternal closure technique that is used as a standard method by many surgeons in Australia and around the world, as this method potentially provides better stability of the sternum and less postoperative sternal pain.  The aim of this research is to compare the outcomes in patients who have their sternum closed either with the Zipfix cable ties or stainless steel wires.  The researchers will investigate whether patients who have their sternum closed with Zipfix cable ties experience less pain compared to patients that have their sternum closed with stainless steel wires.  They will also determine whether patients who have their sternum closed with the cable ties have reduced sternal mobility in the early postoperative period. 

We hypothesize that use of the zipfix system for sternal closure after cardiac surgery improves sternal stability and reduces post operative pain, compared to conventional stainless steel wires.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Silvana Marasco

Address

The Alfred
Department of Cardiothoracic Surgery
55 Commercial Rd.
Melbourne, 3004.
Victoria

Country

Australia

Phone

+613 9076 3313

Fax

s.marasco@alfred.org.au

Contact person for public queries

Name

Silvana Marasco

Address

The Alfred
Department of Cardiothoracic Surgery
55 Commercial Rd.
Melbourne, 3004.
Victoria

Country

Australia

Phone

+613 9076 3313

Fax

s.marasco@alfred.org.au

Contact person for scientific queries

Name

Silvana Marasco

Address

The Alfred
Department of Cardiothoracic Surgery
55 Commercial Rd.
Melbourne, 3004.
Victoria

Country

Australia

Phone

+613 9076 3313

Fax

s.marasco@alfred.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.	2018	https://dx.doi.org/10.1016/j.jtcvs.2018.04.025

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically