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Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

This study is currently recruiting participants.
Verified April 2013 by St. Antonius Hospital
Sponsor:
Information provided by (Responsible Party):
Mario Speth, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01583192
First received: March 23, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Hallux Valgus
Arthritis of the First Metatarsophalangeal Joint
 Procedure: skin preparation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • number of positive swab cultures [ Time Frame: From start surgery week until 48 hours post-operatively ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively


Secondary Outcome Measures:
  • Allergic events [ Time Frame: Until 6 weeks postoperatively ] [ Designated as safety issue: Yes ]
    we will look at the number of allergic events occuring.


Estimated Enrollment: 80
Study Start Date: March 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

 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%
Active Comparator: povidine-jodine soluted in alcohol
skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.
 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%

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583192

Contacts
Contact: Mario Speth, MD m.speth@antoniusziekenhuis.nl

Locations
Netherlands
St Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 340 EM
Contact: Marwan Shadid, md         shabas30@hotmail.com    
Contact: Mario Speth, md         m.speth@antoniusziekenhuis.nl    
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Mario Speth, MD St. Antonius Hospital
  More Information

Additional Information:
woundinfection criteria  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mario Speth, MD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01583192     History of Changes
Other Study ID Numbers: mbshadid
Study First Received: March 23, 2012
Last Updated: April 8, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by St. Antonius Hospital:
infection
skin preparation
fore-foot surgery
 chloride-hexidine
povidine-jodine
alcohol

Additional relevant MeSH terms:
Arthritis
Hallux Valgus
Joint Diseases
Musculoskeletal Diseases
Foot Deformities
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Povidone-Iodine
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013