NCT00500669

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

9.5 years

First QC Date

July 12, 2007

Last Update Submit

April 10, 2017

Conditions

Varicose VeinsWound InfectionRecurrence

Keywords

Varicose veinswound infectionrecurrence

Outcome Measures

Primary Outcomes (1)

  • groin wound infection

    Up to 6 weeks post operative

Secondary Outcomes (1)

  • - groin recurrence of varicose veins

    Up to one year post operatively

Study Arms (2)

Betadine

EXPERIMENTAL
Drug: Betadine

Saline

ACTIVE COMPARATOR
Drug: Betadine

Interventions

BetadineDRUG

Topically

BetadineSaline

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

MeSH Terms

Conditions

Varicose VeinsWound InfectionRecurrence

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Stuart Walker, MBBS

    Royal Hobart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Specialist vascular Surgery

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

June 1, 2004

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

AU(1)