Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000180617
Ethics application status
Approved
Date submitted
17/08/2005
Date registered
19/08/2005
Date last updated
19/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Daily Tenderwet dressings vs QID normal Saline compress as wound debridement agents
Scientific title
A Comparison of the effectiveness of daily Tenderwet dressings and QID normal Saline compress as wound debridement agents
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic leg ulcers 276 0
Condition category
Condition code
Alternative and Complementary Medicine 310 310 0 0
Other alternative and complementary medicine
Skin 311 311 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to evaluate replacing 4 times daily saline soaked compresses dressings with Tenderwet Hartmans's pre-soaked daily dressings in the management of chronic wounds.
Intervention code [1] 205 0
Treatment: Other
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 366 0
The primary outcome is to establish the time for each dressing to achieve a sustainable clean wound bed suitable for grafting.
Timepoint [1] 366 0
Secondary outcome [1] 819 0
Pain reported at dressing changes.
Timepoint [1] 819 0
Secondary outcome [2] 820 0
Total cost of each treatment.
Timepoint [2] 820 0

Eligibility
Key inclusion criteria
1. Patients with chronic, slow/non healing (defined as a wound that shows no progress towards healing in 4 weeks) venous or mixed leg ulcers.2. Patients who are able to understand the purpose of the study and give informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients with severe systemic infections;2. Patients with arerial ulcers;3. Patients with severe lymphoedema or excessive wound exudate;4. Patients taking immunosuppressive drugs.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation using a random number sequence generated by MS Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
5/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 369 0
Charities/Societies/Foundations
Name [1] 369 0
WA Nurses Memorial Chariatable Trust
Country [1] 369 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital & Health Service
Address
Country
Australia
Secondary sponsor category [1] 292 0
None
Name [1] 292 0
None
Address [1] 292 0
Country [1] 292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1356 0
Fremantle Hospital & Health Service
Ethics committee address [1] 1356 0
Ethics committee country [1] 1356 0
Australia
Date submitted for ethics approval [1] 1356 0
Approval date [1] 1356 0
Ethics approval number [1] 1356 0

Summary
Brief summary
The study will evaluate the ability of a new wound cleaning product (TenderWet) to achieve a clean wound when compared with traditional saline soaked gauze dressings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36074 0
Address 36074 0
Country 36074 0
Phone 36074 0
Fax 36074 0
Email 36074 0
Contact person for public queries
Name 9394 0
Annie Thompson
Address 9394 0
Clinical Nurse Manager
PO Box 480
Fremantle WA 6959
Country 9394 0
Australia
Phone 9394 0
+61 8 94312363
Fax 9394 0
+61 8 94312443
Email 9394 0
[email protected]
Contact person for scientific queries
Name 322 0
Sunita McGowan
Address 322 0
Director Nursing Research & Evaluation
PO Box 480
Fremantle WA 6959
Country 322 0
Australia
Phone 322 0
+61 8 94312129
Fax 322 0
+61 8 94312443
Email 322 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.