Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000729628
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
11/11/2005
Date last updated
14/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A casenote audit of the efficacy of applying removable rigid dressings post transtibial amputation.
Scientific title
Removable rigid dressings - an evidence based retrospective study to determine the validity of post transtibial amputation application: a case note audit.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transtibial amputation 881 0
Condition category
Condition code
Musculoskeletal 949 949 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Removable rigid dressings - the application of a synthetic cast removable rigid dressing over the residuum typically whilst the patient was in recovery following their transtibial amputation.
Intervention code [1] 376 0
Not applicable
Comparator / control treatment
Soft dressings - the application of traditional crepe bandaging by a member of the surgical team post-operatively followed by the use of elastic bandaging on advice from a Rehabilitation Specialist.
Control group
Historical

Outcomes
Primary outcome [1] 1247 0
Number of days from amputation to cast for first prosthesis.
Timepoint [1] 1247 0
Discharge from rehabilitation
Secondary outcome [1] 2268 0
Number of interim prostheses provided.
Timepoint [1] 2268 0
Discharge from rehabiliation
Secondary outcome [2] 2269 0
Length of stay in rehabilitation.
Timepoint [2] 2269 0
Discharge from rehabilitation

Eligibility
Key inclusion criteria
All patients who underwent a transtibial amputation two years prior to the introduction of removable rigid dressings to the hospital. All patients who underwent a transtibial amputation two years since the introduction of removable rigid dressings to the hospital.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2005
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] 1046 0
Self funded/Unfunded
Name [1] 1046 0
Country [1] 1046 0
Primary sponsor type
Individual
Name
Prof. Maria Crotty
Address
Department of Rehabilitation and Aged Care Flinders University Repatriation General Hosptal Daws Rd Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 908 0
None
Name [1] 908 0
None
Address [1] 908 0
Country [1] 908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2347 0
Repatriation General Hospital
Ethics committee address [1] 2347 0
Ethics committee country [1] 2347 0
Australia
Date submitted for ethics approval [1] 2347 0
Approval date [1] 2347 0
Ethics approval number [1] 2347 0

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

Contacts
Principal investigator
Name 35288 0
Address 35288 0
Country 35288 0
Phone 35288 0
Fax 35288 0
Email 35288 0
Contact person for public queries
Name 9565 0
Professor Maria Crotty
Address 9565 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hosptal
Daws Rd
Daw Park SA 5041
Country 9565 0
Australia
Phone 9565 0
+61 8 82751103
Fax 9565 0
+61 8 82751130
Email 9565 0
[email protected]
Contact person for scientific queries
Name 493 0
Professor Maria Crotty
Address 493 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hosptal
Daws Rd
Daw Park SA 5041
Country 493 0
Australia
Phone 493 0
+61 8 82751103
Fax 493 0
+61 8 82751130
Email 493 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.