Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583192
• Other study ID #: mbshadid
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2012
• Last updated: June 6, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis of the First Metatarsophalangeal Joint
• Hallux Valgus

Intervention

Procedure:
• 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%

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	wound infection	we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively	until 6 weeks postoperatively	No
Secondary	Allergic events	we will look at the number of allergic events occuring.	Until 6 weeks postoperatively	Yes

External Links

•   woundinfection criteria