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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500669
First Posted: July 13, 2007
Last Update Posted: April 12, 2017
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stuart Walker, Royal Hobart Hospital
  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
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
Topically
Active Comparator: Saline Drug: Betadine
Topically

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500669


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

Responsible Party: Stuart Walker, Staff Specialist vascular Surgery, Royal Hobart Hospital
ClinicalTrials.gov Identifier: NCT00500669     History of Changes
Other Study ID Numbers: H0011
First Submitted: July 12, 2007
First Posted: July 13, 2007
Last Update Posted: April 12, 2017
Last Verified: April 2017

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

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