Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

This study is currently recruiting participants.

Verified April 2013 by St. Antonius Hospital

Sponsor:

Information provided by (Responsible Party):

Mario Speth, St. Antonius Hospital

ClinicalTrials.gov Identifier:

NCT01583192

First received: March 23, 2012

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2012

Last Updated Date

April 8, 2013

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

number of positive swab cultures [ Time Frame: From start surgery week until 48 hours post-operatively ] [ Designated as safety issue: No ]
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.
wound infection [ Time Frame: until 6 weeks postoperatively ] [ Designated as safety issue: No ]
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively

Original Primary Outcome Measures ^ICMJE

number of positive swapt cultures [ Time Frame: From start surgery week until 48 hours post-operatively ] [ Designated as safety issue: No ]
During surgery swapt will be taken before skin desinfection, after skin desinfection and at the end of the surgery.

We will count the number of positive swapt cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.
woundinfection [ Time Frame: until 6 weeks post-operativly ] [ Designated as safety issue: No ]
we will count the number of woundinfections, stated by Prezies, for a period of 6 weeks post-operative

Change History

Complete list of historical versions of study NCT01583192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Allergic events [ Time Frame: Until 6 weeks postoperatively ] [ Designated as safety issue: Yes ]

we will look at the number of allergic events occuring.

Original Secondary Outcome Measures ^ICMJE

Allergic events [ Time Frame: Until 6 weeks post-operatively ] [ Designated as safety issue: Yes ]

we will look at the number of allergic events occuring.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Hallux Valgus
Arthritis of the First Metatarsophalangeal Joint

Intervention ^ICMJE

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%

Study Arm (s)

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

Intervention: Procedure: skin preparation
Active Comparator: povidine-jodine soluted in alcohol
skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.

Intervention: Procedure: skin preparation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mario Speth, MD

m.speth@antoniusziekenhuis.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01583192

Other Study ID Numbers ^ICMJE

mbshadid

Has Data Monitoring Committee

Responsible Party

Mario Speth, St. Antonius Hospital

Study Sponsor ^ICMJE

St. Antonius Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mario Speth, MD

St. Antonius Hospital

Information Provided By

St. Antonius Hospital

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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