Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

St. Antonius Hospital

Status and phase: Completed; Phase 3

Conditions: Hallux Valgus; Arthritis of the First Metatarsophalangeal Joint

Treatments: Procedure: skin preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT01583192

mbshadid

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

chloride-hexidine soluted in alcohol

Active Comparator group

Description:

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

Treatment:

Procedure: skin preparation

povidine-jodine soluted in alcohol

Active Comparator group

Description:

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

Treatment:

Procedure: skin preparation