The Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing the Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns; Comparison to Conventional Treatments

Conditions
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Skin Burns

Intervention / Treatment
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* Drug: povidone iodine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: skin burns in children Exclusion Criteria: allergy to iodine

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: povidone iodine<br> | Drug: povidone iodine<br>* one local application of 10% povidone iodine ointment<br>* Other names: polydine ointment;|
| Active Comparator: cold water<br>treatment by cold water after burn | Drug: povidone iodine<br>* one local application of 10% povidone iodine ointment<br>* Other names: polydine ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar prevention | povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin, burn, povidone iodine, cold water