Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000099820
Ethics application status
Approved
Date submitted
17/01/2012
Date registered
20/01/2012
Date last updated
18/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining risk factors for surgical wound dehiscence (splitting) after surgery and the development of a surgical wound dehiscence risk tool (SWDRT).
Scientific title
Retrospective case control study of surgical wound dehiscence and development of a prospectively validated surgical wound dehiscence risk tool (SWDRT).
Secondary ID [1] 279747 0
NIL
Universal Trial Number (UTN)
U1111-1127-2630
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical wound dehiscence 285605 0
Condition category
Condition code
Other 285799 285799 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Skin 285800 285800 0 0
Other skin conditions
Surgery 285814 285814 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Historical observational study - case review of community patients over 12 months from Janaury 2010 to January 2011 (Silver Chain data) who have recieved treatment for a surgical wound dehiscence after surgery.
Intervention code [1] 284059 0
Not applicable
Comparator / control treatment
Historical - the study will involve a patient case note review from community nursing service (Silver Chain) for treatment over a 12 month period. The study will also involve a case control note review at the matching hospitals where applicable(Royal Perth Hospital, Sir Charles Gardiner Hospital, Fremantle Hospital) for treatment over a 12 month period January 2010 to January 2011.
Control group
Historical

Outcomes
Primary outcome [1] 286310 0
Variables will be listed as being associated with surgical wound dehiscence. Variables will be subject to statistical analysis to determine the significance of each variable.
Timepoint [1] 286310 0
The data to be reviewed would have been collected over a period of one year.
Secondary outcome [1] 295587 0
Development of diagnostic tool from the statistical analysis of the variables derived from the case control review.
Timepoint [1] 295587 0
Twelve months timepoint relative to the period over which the data was collected.

Eligibility
Key inclusion criteria
Discharged patients with surgical wound dehiscence
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, patients under 18 years, patients with abdominal compartment syndrome, patients with open abdomen.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
676
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284529 0
Government body
Name [1] 284529 0
CRC Wound Innovation Grant
Country [1] 284529 0
Australia
Primary sponsor type
Government body
Name
CRC Wound Innovation Grant
Address
Level 2

8 Carraway Street

KELVIN GROVE QLD 4059
Country
Australia
Secondary sponsor category [1] 283458 0
University
Name [1] 283458 0
Curtin University
Address [1] 283458 0
Hayman Rd
Bentley WA 6102
Country [1] 283458 0
Australia
Other collaborator category [1] 260455 0
Other
Name [1] 260455 0
Silver Chain Nursing Service
Address [1] 260455 0
Sundercombe Street,
Osborne Park,
Perth WA 6017
Country [1] 260455 0
Australia
Other collaborator category [2] 260456 0
Hospital
Name [2] 260456 0
Royal Perth Hospital
Address [2] 260456 0
Wellington Street
Perth WA 6000
Country [2] 260456 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286514 0
Silver Chain
Ethics committee address [1] 286514 0
Ethics committee country [1] 286514 0
Australia
Date submitted for ethics approval [1] 286514 0
01/02/2012
Approval date [1] 286514 0
Ethics approval number [1] 286514 0
ECP074

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

Contacts
Principal investigator
Name 33645 0
Address 33645 0
Country 33645 0
Phone 33645 0
Fax 33645 0
Email 33645 0
Contact person for public queries
Name 16892 0
Kylie Sandy-Hodgetts
Address 16892 0
Research Project Officer
Curtin University
Hayman Rd
Bentley WA 6102
Country 16892 0
Australia
Phone 16892 0
+61 08 9266 2212
Fax 16892 0
Email 16892 0
[email protected]
Contact person for scientific queries
Name 7820 0
Professor Keryln Carville
Address 7820 0
Silver Chain
Sundercombe St
Osborne Park
WA 6102
Country 7820 0
Australia
Phone 7820 0
+61 08 9242 0242
Fax 7820 0
Email 7820 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Sandy-Hodgetts, K. Carville, K., Parsons, R., Sant... [More Details]

Documents added automatically
No additional documents have been identified.