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

Not Applicable

• Conditions: Skin Burns
• Interventions: Drug: povidone iodine

• Registration Number: NCT01350713
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Status Verified: 2011-05
• Study First Submitted: 2011-05-08
• Study First Submitted QC: 2011-05-09
• Last Update Submitted: 2011-05-09
• Study First Posted: 2011-05-10
• Last Update Posted: 2011-05-10
• Study Start: 2011-07
• Primary Completion: 2012-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• skin burns in children

Exclusion Criteria

• allergy to iodine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
povidone iodine	povidone iodine	-
cold water	povidone iodine	treatment by cold water after burn

Primary Outcome Measures

Name	Time	Method
prevention of skin lesions caused by exposure to heat source	1 year	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

Name	Time	Method
scar prevention	1 year	povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars)

Trial Locations

Locations (1)

Sherute Briut Clalit; 🇮🇱 Tel Aviv Region, Gush Dan, Heifa, Beer Sheva, Israel