Back to resultsChloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
Primary Purpose
Hallux Valgus, Arthritis of the First Metatarsophalangeal Joint
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
skin preparation
Sponsored by
About this trial
This is an interventional prevention trial for Hallux Valgus focused on measuring infection, skin preparation, fore-foot surgery, chloride-hexidine, povidine-jodine, alcohol
Eligibility 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
Sites / Locations
- St Antonius Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
chloride-hexidine soluted in alcohol
povidine-jodine soluted in alcohol
Arm Description
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
skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.
Outcomes
Primary Outcome Measures
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.
wound infection
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively
Secondary Outcome Measures
Allergic events
we will look at the number of allergic events occuring.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01583192
Brief Title
Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
Official Title
Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Arthritis of the First Metatarsophalangeal Joint
Keywords
infection, skin preparation, fore-foot surgery, chloride-hexidine, povidine-jodine, alcohol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chloride-hexidine soluted in alcohol
Arm Type
Active Comparator
Arm Description
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
Arm Title
povidine-jodine soluted in alcohol
Arm Type
Active Comparator
Arm Description
skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.
Intervention Type
Procedure
Intervention Name(s)
skin preparation
Intervention Description
skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%
Primary Outcome Measure Information:
Title
number of positive swab cultures
Description
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.
Time Frame
From start surgery week until 48 hours post-operatively
Title
wound infection
Description
we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively
Time Frame
until 6 weeks postoperatively
Secondary Outcome Measure Information:
Title
Allergic events
Description
we will look at the number of allergic events occuring.
Time Frame
Until 6 weeks postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Speth, MD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
340 EM
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://www.prezies.nl/zkh/definities/Definities_POWI_2012.pdf
Description
woundinfection criteria
Learn more about this trial
Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
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