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

This study is not yet open for participant recruitment.
Verified May 2011 by Meir Medical Center
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01350713
First received: May 8, 2011
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Skin Burns
 Drug: povidone iodine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing the Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns; Comparison to Conventional Treatments

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • prevention of skin lesions caused by exposure to heat source [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars)


Estimated Enrollment: 280
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: povidone iodine Drug: povidone iodine
one local application of 10% povidone iodine ointment
Other Name: polydine ointment
Active Comparator: cold water
treatment by cold water after burn
 Drug: povidone iodine
one local application of 10% povidone iodine ointment
Other Name: polydine ointment

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • skin burns in children

Exclusion Criteria:

  • allergy to iodine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350713

Contacts
Contact: Arieh Bahir, MD 0544-522877 abahir@clalit.org.il

Locations
Israel
Sherute Briut Clalit Not yet recruiting
Tel Aviv Region, Gush Dan, Heifa, Beer Sheva, Israel, 59501
Principal Investigator: Arieh Bahir, MD            
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Arieh Bahir, MD Sherute Briut Clalit
  More Information

No publications provided

Responsible Party: Arie Bahir, Sherute Briut Clalit ( HMO)
ClinicalTrials.gov Identifier: NCT01350713     History of Changes
Other Study ID Numbers: 060/2011K
Study First Received: May 8, 2011
Last Updated: May 9, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
skin
burn
povidone iodine
cold water

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Povidone
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013