Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

NCT ID: NCT01583192

Last Updated: 2014-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Hallux Valgus Arthritis of the First Metatarsophalangeal Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

skin preparation

Intervention Type PROCEDURE

skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%

povidine-jodine soluted in alcohol

skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.

Group Type ACTIVE_COMPARATOR

skin preparation

Intervention Type PROCEDURE

skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%

Interventions

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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%

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mario Speth

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mario Speth, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Related Links

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Other Identifiers

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mbshadid

Identifier Type: -

Identifier Source: org_study_id

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