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

May 9, 2011 updated by: Meir Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
    • Gush Dan, Heifa, Beer Sheva
      • Tel Aviv Region, Gush Dan, Heifa, Beer Sheva, Israel, 59501
        • sherute briut clalit
        • Principal Investigator:
          • Arieh Bahir, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • skin burns in children

Exclusion Criteria:

  • allergy to iodine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: povidone iodine
Drug: povidone iodine
one local application of 10% povidone iodine ointment
Other Names:
  • polydine ointment
Active Comparator: cold water
treatment by cold water after burn
Drug: povidone iodine
one local application of 10% povidone iodine ointment
Other Names:
  • polydine ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of skin lesions caused by exposure to heat source
Time Frame: 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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Arieh Bahir, MD, sherute briut clalit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

May 8, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060/2011K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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