Trial Review

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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] 1145 0
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 252273 0
The ease of application and removal between the two dressings 252274 0
Comparison of the ease of application and removal between the two dressings 252275 0
Comparison of pain assoicated with the application and removal of the two dressings 252276 0
Condition category
Condition code
Injuries and Accidents 252352 252352 0 0
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] 241521 0
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] 253315 0
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] 253315 0
Weekly until removal of K-wire (usually up to 8 weeks)
Secondary outcome [1] 262386 0
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] 262386 0
At each dressing change
Secondary outcome [2] 262387 0
Pain on removal of dressing will be assessed using a visual analog pain scale ( 0 - 10)
Timepoint [2] 262387 0
At each dressing change
Secondary outcome [3] 262388 0
Need for cleanining of pin site will be assessed using Yes (pin site needs cleaning) or No (pin site is clean)
Timepoint [3] 262388 0
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] 244066 0
Hospital
Name [1] 244066 0
Peninsula health
Country [1] 244066 0
Australia
Funding source category [2] 244067 0
Commercial sector/Industry
Name [2] 244067 0
Smith and Nephew
Country [2] 244067 0
Australia
Primary sponsor type
Hospital
Name
Peninsula health
Address
PO Box 52
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 251412 0
None
Name [1] 251412 0
Address [1] 251412 0
Country [1] 251412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258165 0
Peninsula Health
Ethics committee address [1] 258165 0
PO Box 52
Frankston VIC 3199
Ethics committee country [1] 258165 0
Australia
Date submitted for ethics approval [1] 258165 0
26/10/2009
Approval date [1] 258165 0
09/11/2009
Ethics approval number [1] 258165 0
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 30480 0
Dr Patricia Terrill
Address 30480 0
Frankston Hospital, department of surgery
PObox52
Frankston Vic3199
Country 30480 0
Australia
Phone 30480 0
613 9784 8416
Fax 30480 0
Email 30480 0
arizzitelli@phcn.vic.gov.au
Contact person for public queries
Name 13727 0
Dr Dr Patricia Terill
Address 13727 0
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 13727 0
Australia
Phone 13727 0
+61 3 9784 7777
Fax 13727 0
Email 13727 0
arizzitelli@phcn.vic.gov.au
Contact person for scientific queries
Name 4655 0
Dr Dr Patricia Terill
Address 4655 0
Frankston Hospital
PO Box 52
Frankston VIC 3199
Country 4655 0
Australia
Phone 4655 0
+61 3 9784 7777
Fax 4655 0
Email 4655 0
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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