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

This study is currently recruiting participants.

Verified by Royal Hobart Hospital, July 2007

Sponsored by:	Royal Hobart Hospital
Information provided by:	Royal Hobart Hospital
ClinicalTrials.gov Identifier:	NCT00500669

Purpose

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

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

MedlinePlus related topics: Varicose Veins

Drug Information available for: Povidone-iodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	A Randomised, Blinded Study to Assess the Effect of Betadine in the Groin Wound of Patients Undergoing Primary Varicose Vein Surgery

Further study details as provided by Royal Hobart Hospital:

Primary Outcome Measures:

groin wound infection

Secondary Outcome Measures:

– groin recurrence of varicose veins

Estimated Enrollment:	60
Study Start Date:	June 2004
Estimated Study Completion Date:	July 2008

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

Study ID Numbers:	H0011
Study First Received:	July 12, 2007
Last Updated:	July 12, 2007
ClinicalTrials.gov Identifier:	NCT00500669
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Royal Hobart Hospital:

Varicose veins
wound infection
recurrence

Study placed in the following topic categories:

Varicose Veins
Povidone
Wounds and Injuries
Vascular Diseases
Iodine

Disorders of Environmental Origin
Povidone-Iodine
Recurrence
Wound Infection

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Infective Agents, Local
Disease Attributes
Pathologic Processes

Therapeutic Uses
Cardiovascular Diseases
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009