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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00500669




Registration number
NCT00500669
Ethics application status
Date submitted
12/07/2007
Date registered
13/07/2007
Date last updated
12/04/2017

Titles & IDs
Public title
A Randomised Study to Assess Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery
Scientific title
A Randomised, Blinded Study to Assess the Effect of Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery
Secondary ID [1] 0 0
H0011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Varicose Veins 0 0
Wound Infection 0 0
Recurrence 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Betadine

Experimental: Betadine -

Active Comparator: Saline -


Treatment: Drugs: Betadine
Topically
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
groin wound infection
Timepoint [1] 0 0
Up to 6 weeks post operative
Secondary outcome [1] 0 0
- groin recurrence of varicose veins
Timepoint [1] 0 0
Up to one year post operatively

Eligibility
Key inclusion criteria
- Patients undergoing primary saphenofemoral ligation for varicose veins (can be
combined with short saphenous surgery).
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Allergy to iodine

- Redo groin dissections

- Patients having multiple avulsions only or saphenopopliteal ligation only

- Patients unable to return to outpatients for 6 weeks to undergo assessment with the
wound care nurse

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
7001 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Hobart Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To investigate whether Betadine can reduce infection rates and recurrence rates following
varicose veins surgery in a randomized double blind placebo controlled study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00500669
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart Walker, MBBS
Address 0 0
Royal Hobart Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00500669