Back to resultsThe Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns
Primary Purpose
Skin Burns
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
povidone iodine
Sponsored by
About this trial
This is an interventional treatment trial for Skin Burns focused on measuring skin, burn, povidone iodine, cold water
Eligibility Criteria
Inclusion Criteria:
- skin burns in children
Exclusion Criteria:
- allergy to iodine
Sites / Locations
- Sherute Briut Clalit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
povidone iodine
cold water
Arm Description
treatment by cold water after burn
Outcomes
Primary Outcome Measures
prevention of skin lesions caused by exposure to heat source
Skin exposed to hot liquid or metal that topically treated with povidone-iodine will show no or slight irritation while individuals treated with the standard cold water will show strong skin irritation including erythema and blisters.
Secondary Outcome Measures
scar prevention
povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01350713
Brief Title
The Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns
Official Title
Testing the Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns; Comparison to Conventional Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Skin burns are one of the causes of disability, suffering and death in humans. Anecdotal, uncontrolled studies have shown the efficacy of povidone-iodine ointment in human skin burns, provided the preparation was applied shortly after the exposure to the heat source. The proposed study will conduct a controlled study in which the effect of povidone-iodine ointment will be tested in large group of patients and will be compared with standard cold water treatment.
Detailed Description
Skin burns are one of the causes of disability, suffering and death in humans. The current treatment includes application of cold water or other plant origin preparations. However non of these treatments was shown to be efficacious.
Animal studies have demonstrated the pronounced protective effect of povidone-iodine ointment against thermal burns. Moreover, anecdotal, uncontrolled studies in humans have shown the efficacy of povidone-iodine ointment in human skin burns, provided the preparation was applied shortly after the exposure to the heat source. The proposed study will conduct a controlled study in which the effect of povidone-iodine ointment will be tested in large group of patients and will be compared with standard cold water treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Burns
Keywords
skin, burn, povidone iodine, cold water
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
povidone iodine
Arm Type
Experimental
Arm Title
cold water
Arm Type
Active Comparator
Arm Description
treatment by cold water after burn
Intervention Type
Drug
Intervention Name(s)
povidone iodine
Other Intervention Name(s)
polydine ointment
Intervention Description
one local application of 10% povidone iodine ointment
Primary Outcome Measure Information:
Title
prevention of skin lesions caused by exposure to heat source
Description
Skin exposed to hot liquid or metal that topically treated with povidone-iodine will show no or slight irritation while individuals treated with the standard cold water will show strong skin irritation including erythema and blisters.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
scar prevention
Description
povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
skin burns in children
Exclusion Criteria:
allergy to iodine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arieh Bahir, MD
Phone
0544-522877
Email
abahir@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arieh Bahir, MD
Organizational Affiliation
Sherute Briut Clalit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherute Briut Clalit
City
Tel Aviv Region
State/Province
Gush Dan, Heifa, Beer Sheva
ZIP/Postal Code
59501
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arieh Bahir, MD
12. IPD Sharing Statement
Learn more about this trial
The Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns
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