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

NCT01350713 | Unknown

• 1 other identifier: 060/2011K
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Burns

Keywords

skin; burn; povidone iodine; cold water

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• scar prevention

  1 year

Study Arms (2)

povidone iodine

EXPERIMENTAL

Drug: povidone iodine

cold water

ACTIVE COMPARATOR

treatment by cold water after burn

Drug: povidone iodine

Interventions

povidone iodine DRUG

one local application of 10% povidone iodine ointment

Also known as: polydine ointment

cold water; povidone iodine

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• skin burns in children

You may not qualify if:

• allergy to iodine

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Sherute Briut Clalit

Tel Aviv Region, Gush Dan, Heifa, Beer Sheva, 59501, Israel

Location

MeSH Terms

Conditions

Paresthesia; Burns

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Arieh Bahir, MD

  Sherute Briut Clalit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arieh Bahir, MD

CONTACT

0544-522877; abahir@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2011
• First Posted: May 10, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

IL (1)