Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

June 6, 2014 updated by: Mario Speth, St. Antonius Hospital

Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery

The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.

There will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 340 EM
        • St Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age above 18 years
  • written informed consent
  • indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint

Exclusion Criteria:

  • allergic for jodine-povidine and/or chloride-hexidine
  • active infection
  • skin defect
  • blood clotting or coagulation disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: chloride-hexidine soluted in alcohol

patients will have skin preparation with chloride-hexidine soluted in alcohol prior to their forefoot surgery.

Skin swabs will be taken prior to skin preparation, after skin preparation and after skin closure at the end of the operation
Procedure: skin preparation
skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%
Active Comparator: povidine-jodine soluted in alcohol
skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.
Procedure: skin preparation
skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of positive swab cultures
Time Frame: From start surgery week until 48 hours post-operatively

During surgery swabs will be taken before skin desinfection, after skin desinfection and at the end of the surgery.

We will count the number of positive swab cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.
From start surgery week until 48 hours post-operatively
wound infection
Time Frame: until 6 weeks postoperatively
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively
until 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allergic events
Time Frame: Until 6 weeks postoperatively
we will look at the number of allergic events occuring.
Until 6 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: Mario Speth, MD, St. Antonius Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Estimate)

June 9, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mbshadid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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