Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000743066
Ethics application status
Approved
Date submitted
26/08/2010
Date registered
7/09/2010
Date last updated
7/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reduction of Surgical Site Infection in Cardiac Surgery using a Microbial Sealant-A Controlled Study
Scientific title
In coronary artery bypass patients requiring greater than 2 lengths of saphenous vein for conduit does the application of a cyanoacrylate surgical sealant prior to leg wound incision decrease wound infection rates scored at 1 month
when compared to the contralateral leg wound in the same patient.
Secondary ID [1] 252577 0
Nil
Universal Trial Number (UTN)
U1111-1116-7201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infection 258064 0
Condition category
Condition code
Surgery 258225 258225 0 0
Surgical techniques
Cardiovascular 258314 258314 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of a cyanoacrylate microbial surgical sealant to the skin surface immediately prior to skin incision for removal of the long saphenous vein for coronary artery bypass surgery.
Applied directly from sterile container with sponge applicator. Probable mechanism of action is the fixation of microorganisms within hair follicles and sweat glands, thus reducing quantitatively the contamination of the incision.
Intervention code [1] 257096 0
Treatment: Surgery
Comparator / control treatment
The contralateral leg wound in the same patient. This is managed in an identical fashion to the treatment (ie Sealant applied leg) other than the application of the sealant.
Control group
Active

Outcomes
Primary outcome [1] 259084 0
Wound infection, scored by blinded observors according to Southampton wound score system
Timepoint [1] 259084 0
At 1 month following surgery
Secondary outcome [1] 265373 0
wound swab microbial culture
Timepoint [1] 265373 0
At 5 days post operatively.

Eligibility
Key inclusion criteria
Isolated Coronary Artery bypass patients requiring greater than 2 lengths of saphenous vein conduit.
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Peripheral vascular disease, long saphenous vein abnormality, leg skin lesions or ulcers, prior sensitivity to cyanoacrlate, acetone or formaldehyde containg products, non consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients presenting for isolated coronary artery bypass grafts (CABG) requiring > 2 lengths of saphenous conduit, without exclusion features. allocation not concealed. Alternate application of sealant sequentially to left or right leg in consecutive patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257542 0
Self funded/Unfunded
Name [1] 257542 0
Ian Gilfillan
Country [1] 257542 0
Australia
Primary sponsor type
Individual
Name
Ian Gilfillan
Address
Fremantle Hospital
Alma Street
Fremantle
Western Australia 6160
Country
Australia
Secondary sponsor category [1] 256767 0
None
Name [1] 256767 0
Address [1] 256767 0
Country [1] 256767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259570 0
Department Of Health, South Metropolitan Area Health, Human Research Ethics Committee
Ethics committee address [1] 259570 0
Ethics committee country [1] 259570 0
Australia
Date submitted for ethics approval [1] 259570 0
Approval date [1] 259570 0
02/07/2008
Ethics approval number [1] 259570 0
08/90

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31576 0
Address 31576 0
Country 31576 0
Phone 31576 0
Fax 31576 0
Email 31576 0
Contact person for public queries
Name 14823 0
Ian Gilfillan
Address 14823 0
Fremantle hospital
Alma Street
Fremantle
Western Australia
6160
Country 14823 0
Australia
Phone 14823 0
+61894313337
Fax 14823 0
Email 14823 0
[email protected]
Contact person for scientific queries
Name 5751 0
Ian Gilfillan
Address 5751 0
Fremantle hospital
Alma Street
Fremantle
Western Australia
6160
Country 5751 0
Australia
Phone 5751 0
+61894313337
Fax 5751 0
Email 5751 0
[email protected]

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
No additional documents have been identified.