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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chloride-hexidine soluted in alcohol | Active Comparator | 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 |
|
| povidine-jodine soluted in alcohol | Active Comparator | skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| skin preparation | Procedure | skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70% |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Allergic events | we will look at the number of allergic events occuring. | Until 6 weeks postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Speth, MD | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Antonius Hospital | Nieuwegein | Utrecht | 340 EM | Netherlands |
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| Label | URL |
|---|---|
| woundinfection criteria | View source |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D007239 | Infections |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D062327 | Skin Lightening Preparations |
| ID | Term |
|---|---|
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
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| D013676 |
| Technology, Industry, and Agriculture |