Text Size

A Randomised Study to Assess Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Royal Hobart Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Hobart Hospital
ClinicalTrials.gov Identifier:
NCT00500669
First received: July 12, 2007
Last updated: March 15, 2010
Last verified: March 2010
History of Changes
  Purpose

To investigate whether Betadine can reduce infection rates and recurrence rates following varicose veins surgery in a randomized double blind placebo controlled study.


Condition Intervention Phase
Varicose Veins
Wound Infection
Recurrence
 Drug: Betadine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Randomised, Blinded Study to Assess the Effect of Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery

Resource links provided by NLM:

MedlinePlus related topics: Varicose Veins
U.S. FDA Resources

Further study details as provided by Royal Hobart Hospital:

Primary Outcome Measures:
  • groin wound infection [ Time Frame: Up to 6 weeks post operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • - groin recurrence of varicose veins [ Time Frame: Up to one year post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Betadine
    Topically
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing primary saphenofemoral ligation for varicose veins (can be combined with short saphenous surgery).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500669

Contacts
Contact: Stuart Walker, MBBS 03 62227064 stuart.walker@dhhs.tas.gov.au

Locations
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7001
Contact: Stuart Walker         stuart.walker@dhhs.tas.gov.au    
Sponsors and Collaborators
Royal Hobart Hospital
Investigators
Principal Investigator: Stuart Walker, MBBS Royal Hobart Hospital
  More Information

No publications provided

Responsible Party: Mr Stuart Walker, Royal Hobart Hospital
ClinicalTrials.gov Identifier: NCT00500669     History of Changes
Other Study ID Numbers: H0011
Study First Received: July 12, 2007
Last Updated: March 15, 2010
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Royal Hobart Hospital:
Varicose veins
wound infection
recurrence

Additional relevant MeSH terms:
Recurrence
Varicose Veins
Wound Infection
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
 Infection
Wounds and Injuries
Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013