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Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

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ClinicalTrials.gov Identifier: NCT01583192
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Mario Speth, St. Antonius Hospital

Tracking Information
First Submitted Date  ICMJE March 23, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date June 9, 2014
Study Start Date  ICMJE March 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • number of positive swapt cultures [ Time Frame: From start surgery week until 48 hours post-operatively ]
    During surgery swapt will be taken before skin desinfection, after skin desinfection and at the end of the surgery. We will count the number of positive swapt cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.
  • woundinfection [ Time Frame: until 6 weeks post-operativly ]
    we will count the number of woundinfections, stated by Prezies, for a period of 6 weeks post-operative
Change History Complete list of historical versions of study NCT01583192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
Allergic events [ Time Frame: Until 6 weeks postoperatively ]
we will look at the number of allergic events occuring.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Allergic events [ Time Frame: Until 6 weeks post-operatively ]
we will look at the number of allergic events occuring.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
Official Title  ICMJE Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hallux Valgus
  • Arthritis of the First Metatarsophalangeal Joint
Intervention  ICMJE 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%
Study Arms  ICMJE
  • Active Comparator: chloride-hexidine soluted in alcohol

    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

    Intervention: Procedure: skin preparation
  • Active Comparator: povidine-jodine soluted in alcohol
    skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.
    Intervention: Procedure: skin preparation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
52
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
80
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583192
Other Study ID Numbers  ICMJE mbshadid
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Speth, St. Antonius Hospital
Study Sponsor  ICMJE St. Antonius Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mario Speth, MD St. Antonius Hospital
PRS Account St. Antonius Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP