Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

Phase 3

Completed

• Conditions: Hallux Valgus; Arthritis of the First Metatarsophalangeal Joint
• Interventions: Procedure: skin preparation

• Registration Number: NCT01583192
• Lead Sponsor: St. Antonius Hospital

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 Timeline

• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Study Start: 2013-03
• Primary Completion: 2014-05
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-06
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chloride-hexidine soluted in alcohol	skin preparation	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	skin preparation	skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.

Primary Outcome Measures

Name	Time	Method
number of positive swab cultures	From start surgery week until 48 hours post-operatively	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	until 6 weeks postoperatively	we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively

Secondary Outcome Measures

Name	Time	Method
Allergic events	Until 6 weeks postoperatively	we will look at the number of allergic events occuring.

Trial Locations

Locations (1)

St Antonius Hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands