Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01583192

Enrollment

Registered

2012-04-23

Start date

2013-03-31

Completion date

2014-06-30

Last updated

2014-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis of the First Metatarsophalangeal Joint, Hallux Valgus

Keywords

infection, skin preparation, fore-foot surgery, chloride-hexidine, povidine-jodine, alcohol

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.

Interventions

PROCEDUREskin preparation

skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Allergic events	Until 6 weeks postoperatively	we will look at the number of allergic events occuring.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026