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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:
Information provided by (Responsible Party):
Stuart Walker, Royal Hobart Hospital
ClinicalTrials.gov Identifier:
NCT00500669
First received: July 12, 2007
Last updated: April 10, 2017
Last verified: April 2017
  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: 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 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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: July 12, 2007
Last Updated: April 10, 2017

Keywords provided by 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

ClinicalTrials.gov processed this record on April 28, 2017