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

This study has been terminated.
(Recruitement too slow)
Information provided by (Responsible Party):
Stuart Walker, Royal Hobart Hospital Identifier:
First received: July 12, 2007
Last updated: April 10, 2017
Last verified: April 2017
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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:

Further study details as provided by Stuart Walker, Royal Hobart Hospital:

Primary Outcome Measures:
  • groin wound infection [ Time Frame: Up to 6 weeks post operative ]

Secondary Outcome Measures:
  • - groin recurrence of varicose veins [ Time Frame: Up to one year post operatively ]

Enrollment: 60
Study Start Date: June 2004
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Betadine Drug: Betadine
Active Comparator: Saline Drug: Betadine

  Show Detailed Description


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00500669

Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Sponsors and Collaborators
Royal Hobart Hospital
Principal Investigator: Stuart Walker, MBBS Royal Hobart Hospital
  More Information

Responsible Party: Stuart Walker, Staff Specialist vascular Surgery, Royal Hobart Hospital Identifier: NCT00500669     History of Changes
Other Study ID Numbers: H0011
Study First Received: July 12, 2007
Last Updated: April 10, 2017

Keywords provided by Stuart Walker, Royal Hobart Hospital:
Varicose veins
wound infection

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Varicose Veins
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Anti-Infective Agents, Local
Anti-Infective Agents processed this record on September 21, 2017