ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609001023246

Ethics application status

Approved

Date submitted

23/11/2009

Date registered

25/11/2009

Date last updated

8/12/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

A prospective randomized control trial comparing a non adherent dry dressing with a silver foam dressing in the management of Kirscher wire (K-wire) pin sites in the closed fractures of the hand.

Scientific title

A prospective randomized control trial comparing a non adherent dry dressing with a silver foam dressing in the management of Kirscher wire (K-wire) pin sites in the closed fractures of the hand.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

The incidence of infection after K-wire insertion using a dry non-adherent and a wet wound dressing

The ease of application and removal between the two dressings

Comparison of the ease of application and removal between the two dressings

Comparison of pain assoicated with the application and removal of the two dressings

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The K-wire is inserted as per normal surgical practice. The wound is dressed using the dry dressing. As per standard clinical practice - the patient attends outpatients weekly for up to 8 weeks The dressing is assessed at each appointment as to whether it needs changing. .K-wire removal usually occurring after 4 weeks.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The K-wire is inserted as per normal surgical practice. The wound is dressed with the silver foam dressing which is a wet dressing (compared to the dry control dressing). As per standard clinical practice - the patient attends outpatients weekly for up to 8 weeks. The dressing is assessed at each appointment to assess whether it needs changing. K-wire removal usually occurring after 4 weeks.

Control group

Active

Outcomes

Primary outcome [1]

The wound will be photographed at each weekly outpatient appointment and assessed on a pin infection rate scale (Sims and Saleh 1996). Temperature, Full blood examination (FBE), erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), X-ray will be done if the infection is graded at 3 or above.

Timepoint [1]

Weekly until removal of K-wire (usually up to 8 weeks)

Secondary outcome [1]

Ease of removal and application at each dressing change will be assessed using a 5 point scale (very easy through to very difficult)

Timepoint [1]

At each dressing change

Secondary outcome [2]

Pain on removal of dressing will be assessed using a visual analog pain scale ( 0 - 10)

Timepoint [2]

At each dressing change

Secondary outcome [3]

Need for cleanining of pin site will be assessed using Yes (pin site needs cleaning) or No (pin site is clean)

Timepoint [3]

At each dressing change

Eligibility

Key inclusion criteria

Closed fractures of the hand distal to the wrist crease

Minimum age

1 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Open fractures

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)

All subjects fitting the inclusion criteria will be invited to participate in the study. Allocation to a treatment group will be done by sealed envelopes.

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

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/01/2010

Actual

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)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Peninsula health

Address [1]

PO Box 52
Frankston VIC 3199

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Smith and Nephew

Address [2]

P O Box 242
Mount Waverley VIC 3149

Country [2]

Australia

Primary sponsor type

Hospital

Name

Peninsula health

Address

PO Box 52
Frankston VIC 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health

Ethics committee address [1]

PO Box 52
Frankston  VIC 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/10/2009

Approval date [1]

09/11/2009

Ethics approval number [1]

2009-66

Summary

Brief summary

This study looks at two types of surgical wound dressing used after fixing fractures of the hand with a pin called a K-wire and whether there is a difference in infection rates and the ease of , and pain associated with, application and removal. 
When a person fractures a bone they may have a closed fracture or an open or compound fracture.  A closed fracture is when the broken bone does not penetrate the skin.  In this study, we are only looking at patients with closed fractures.  In addition, for inclusion in this study, the fracture must be of the hand higher (distal) than the wrist crease.
The Kirscher Wire Pin (commonly known as a K-wire) is a sharpened, sterilised metal pin that is used to hold the fractured bone fragments together.  After insertion of the K-wire, the wound is dressed and then assessed on a weekly basis for infection.  Infection is common (about 10% of cases) because the insertion of the wire through the skin into the bone creates a passage for bacteria. The area around the wire may become red and swollen and there may be a discharge.  Antibiotics may have to be prescribed and sometimes the pin needs to be removed prematurely.
Current practice involves dressing the wound in Melolin – a dry non-adherent sterile dressing and Mefix – a surgical tape.  In this study we would like to compare this dressing with a new anti-microbial barrier dressing which contain nanocrystalline silver.  This type of silver has long been known for its antimicrobial properties. 
The patients would be consented prior to surgery and then randomly allocated one of the two wound dressings.  For both arms of the study, the patients will be followed up and assessed in exactly the same manner.  
If a patient does not wish to participate in the trial the wound will be dressed in the dry dressing as is current practice.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Patricia Terrill

Address

Frankston Hospital, department of surgery
PObox52
Frankston Vic3199

Country

Australia

Phone

613 9784 8416

Fax

arizzitelli@phcn.vic.gov.au

Contact person for public queries

Name

Dr Patricia Terill

Address

Frankston Hospital
PO Box 52
Frankston VIC 3199

Country

Australia

Phone

+61 3 9784 7777

Fax

arizzitelli@phcn.vic.gov.au

Contact person for scientific queries

Name

Dr Patricia Terill

Address

Frankston Hospital
PO Box 52
Frankston VIC 3199

Country

Australia

Phone

+61 3 9784 7777

Fax

arizzitelli@phcn.vic.gov.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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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