Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

Study Overview
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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.

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

Conditions
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Hallux Valgus, Arthritis of the First Metatarsophalangeal Joint

Intervention / Treatment
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* Procedure: skin preparation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chloride-hexidine soluted in alcohol<br>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<br>* skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%<br>|
| Active Comparator: povidine-jodine soluted in alcohol<br>skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery. | Procedure: skin preparation<br>* skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of positive swab cultures | 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 | 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 | we will look at the number of allergic events occuring. | Until 6 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, skin preparation, fore-foot surgery, chloride-hexidine, povidine-jodine, alcohol