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

Skin Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01350713
• Other study ID #: 060/2011K
• Status: Not yet recruiting
• Phase: N/A
• First received: May 8, 2011
• Last updated: May 9, 2011
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2011
• Source: Meir Medical Center
• Contact: Arieh Bahir, MD
• Phone: 0544-522877
• Email: abahir[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• skin burns in children

Exclusion Criteria:

• allergy to iodine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Skin Burns

Intervention

Drug:
• povidone iodine
one local application of 10% povidone iodine ointment

Locations

Country	Name	City	State
Israel	Sherute Briut Clalit	Tel Aviv Region	Gush Dan, Heifa, Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	scar prevention	povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars)	1 year	Yes