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Trial registered on ANZCTR


Registration number
ACTRN12606000094572
Ethics application status
Approved
Date submitted
8/03/2006
Date registered
9/03/2006
Date last updated
11/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the effectiveness of two antimicrobials: A Randomised Controlled Trial
Scientific title
Comparing the effectiveness of nanocrystalline silver dressing and cadexomer iodine in healing leg ulcers: A Randomised Controlled
Secondary ID [1] 253617 0
Silver V Iodine Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Limb Leg Ulcers 1059 0
Condition category
Condition code
Skin 1139 1139 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cadexomer iodine dressing (Iodosorb)

Cadexomer iodine dressing (Iodosorb) is applied topically to the wounds. It is delivered according to the Iodosorb instructions for the wound whilst signs of infection and critical colonisation are evident in the wound. This time period may vary from wound to wound. The criteria for removing the client from the antimicorbial is consistent in the Iodosorb conditions. All participants will be monitored for a three month period.

Within the approved Iodosorb range of products the following dressings would be applied with the following frequency though clinical judgement is permited to alter this scheduled dependent on the wound characteristics (for instance to more frequent dressing changes for highly exudating wounds)
Idosorb Powder (9m/g Iodine) - three daily
Iodosorb Paste (0.9%w/w Iodine Ph. Eur) - three daily

Potentially a study participant could become eligible to cease an antimicrobial 1 week and 1 day after commencing the trial as a minimum time they could receive the treatment with the maximum time a person could receive an antimicrobial being the full three month study period or 12 weeks.
Intervention code [1] 933 0
Treatment: Other
Comparator / control treatment
Nanocrystalline silver dressing (Acticoat)

Nanocrystalline silver dressing (Acticoat) is applied topically to the wounds. It is delivered according to the Acticoat product instructions for the wound whilst signs of infection and critical colonisation are evident in the wound. This time period may vary from wound to wound. The criteria for removing the client from the antimicorbial is consistent in Acticoat conditions. All participants will be monitored for a three month period.

Within the approved Acticoat range of products the following dressings would be applied with the following frequency though clinical judgement is permited to alter this scheduled dependent on the wound characteristics (for instance to more frequent dressing changes for highly exudating wounds)
Acticoat Absorbant - three daily changes
Acticoat 3 - three daily changes
Acticoat 7 - once weekly.
The concentration of ionic silver released from Acticoat is 70-100 ppm.

Potentially a study participant could become eligible to cease an antimicrobial 1 week and 1 day after commencing the trial as a minimum time they could receive the treatment with the maximum time a person could receive an antimicrobial being the full three month study period or 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 1530 0
Wound size
Timepoint [1] 1530 0
Baseline wound size will be determined at recruitment using digital imaging software (AMWIS). Fortnightly wound photographs will be taken until the wound is healed or when the participant completes their three month time on the study.
Primary outcome [2] 1531 0
Percentage of wound healing
Timepoint [2] 1531 0
Basline wound size will be determined at recruitment using digital imaging software (AMWIS). Fortnightly wound photographs will be taken until the wound is healed or when the participant completes their three month time on the study.
Secondary outcome [1] 2764 0
1. Time to healing - to be calculated at baseline and then fortnightly for the remainder of the 3 month study period.
Timepoint [1] 2764 0
Time to healing was calculated from wound size measurements assessed using the Advanced Medical Wound Imaging System V2.2 (AMWIS) software. This software calculates the total surface area of a wound from calibrated digital photographs. Photographs were taken at recruitment (baseline) and at two weekly intervals for 12 weeks or less if the client healed.
A daily healing rate was generated by determining the percentage change in the total surface area between wound size measures.
Secondary outcome [2] 2765 0
2. Wound characteristics -to be calculated at baseline and then fortnightly for the remainder of the 3 month study period.
Timepoint [2] 2765 0
Wound characteristics were assessed using categorical questions regarding the presence of signs of bacterial burden collected at baseline and every 2 weeks for 12 weeks or until healing if this occurs first. The presence of tissue types in the wound was also assessed using the Advanced Medical Wound Imaging System V2.2 (AMWIS) software which allows tracing and sizing of the percentage of the wound represented by different tissue types such as necrotic tissue, slough, granulating tissue etc. Data were collected at recruitment (baseline) and at two weeks for 12 weeks or less if the client healed.
Secondary outcome [3] 2766 0
3. Bacteria type and quantity in wound.
Timepoint [3] 2766 0
To be determined at baseline and then when a client ceases or recommences the antimicrobial treatment baseline on a protocol of signs of infection and critical colonisation, at 6 weeks if the participant has not ceased the use of an antimicrobial and at 12 weeks in the participant is still using an antimicrobial.
Secondary outcome [4] 2767 0
4. Relationship of health status, medication use, and demographic variables with healing.
Timepoint [4] 2767 0
To be ascertained at baseline. Antibiotic use to be further monitored during fortnightly data collection.
Secondary outcome [5] 2768 0
5. Cost of care and resource use to be calculated at baseline and then fortnightly for the remainder of the 3 month study period.
Timepoint [5] 2768 0
Calculated for the total study period - 12 weeks or less if the wound healed
Secondary outcome [6] 2769 0
6. Client satisfaction regarding comfort, pain and impact of treatment.
Timepoint [6] 2769 0
To be determined via a survey administered when the participant completed their antimicrobial treatment or at the end of the three month study period if the client has not ceased the use of the antimicrobial.

Eligibility
Key inclusion criteria
Has a Lower Leg Ulcer (not Pressure Ulcer) with Ankle Brachial Pressure Index (ABPI) of .6 or above Has a wound which must be the major wound and is 15cms or less in diameter.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Client has been on a course of topical antiseptic treatment in the 1 week prior to recruitment Client has been using any antibiotics (e.g. topical, IV, IM, oral) for either wound or other condition 48 hours prior to recruitment Client is using systemic steroids (e.g. oral, IM, IV, rectal). Client has a diagnosis of diabetesClient has a diagnosis of malignancy related to the leg ulcerClient is receiving palliative careClient has a contraindication to either treatment products.

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 opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
MicroSoft Excel random number function
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

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

Funding & Sponsors
Funding source category [1] 1244 0
Charities/Societies/Foundations
Name [1] 1244 0
The Angior Family Foundation
Address [1] 1244 0
Angior Family Foundation
National Australia Trustees Ltd
Docklands 2506UB
GPO Box 247B
MELBOURNE VIC 3001
Country [1] 1244 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Angior Family Foundation
Address
Angior Family Foundation
National Australia Trustees Ltd
Docklands 2506UB
GPO Box 247B
MELBOURNE VIC 3001
Country
Australia
Secondary sponsor category [1] 1099 0
None
Name [1] 1099 0
Nil
Address [1] 1099 0
Country [1] 1099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2577 0
Royal District Nursing Service Research Ethics Committee
Ethics committee address [1] 2577 0
Ethics committee country [1] 2577 0
Australia
Date submitted for ethics approval [1] 2577 0
Approval date [1] 2577 0
17/02/2006
Ethics approval number [1] 2577 0
99
Ethics committee name [2] 2578 0
Silver Chain Nursing Association Research Ethics Committee
Ethics committee address [2] 2578 0
Ethics committee country [2] 2578 0
Australia
Date submitted for ethics approval [2] 2578 0
Approval date [2] 2578 0
22/12/2005
Ethics approval number [2] 2578 0
024

Summary
Brief summary
This study will compare the effectiveness of two different ways of treating leg ulcers that are infected or slow to heal. The treatments being compared are cadexomer iodine (Iodosorb® product range), and a silver impregnated dressing (Acticoat® product range). It is hypothesised that one of these treatments will lead to quicker healing and reduced cost compared to the other commonly used dressing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35240 0
Address 35240 0
Country 35240 0
Phone 35240 0
Fax 35240 0
Email 35240 0
Contact person for public queries
Name 10122 0
Charne Miller
Address 10122 0
Royal District Nursing Service
31 Alma Road
St Kilda VIC 3182
Country 10122 0
Australia
Phone 10122 0
+61 3 95365222
Fax 10122 0
Email 10122 0
cmiller@rdns.com.au
Contact person for scientific queries
Name 1050 0
Charne Miller
Address 1050 0
Royal District Nursing Service
31 Alma Road
St Kilda VIC 3182
Country 1050 0
Australia
Phone 1050 0
+61 3 95365222
Fax 1050 0
Email 1050 0
cmiller@rdns.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary