Skip to main content
OpenTrials
Completed

NCT Number: NCT01583192

Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hallux Valgus Arthritis of the First Metatarsophalangeal Joint Foot Deformities Infections Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Antonius Hospital

Nieuwegein, Utrecht, 340 EM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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%

Primary outcomes

  1. number of positive swab cultures

    Time frame: 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.

  2. wound infection

    Time frame: until 6 weeks postoperatively

    we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively

Secondary outcomes

  1. Allergic events

    Time frame: Until 6 weeks postoperatively

    we will look at the number of allergic events occuring.

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2012
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.