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

NCT ID: NCT01350713

Last Updated: 2011-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Skin Burns

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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povidone iodine

Group Type EXPERIMENTAL

povidone iodine

Intervention Type DRUG

one local application of 10% povidone iodine ointment

cold water

treatment by cold water after burn

Group Type ACTIVE_COMPARATOR

povidone iodine

Intervention Type DRUG

one local application of 10% povidone iodine ointment

Interventions

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povidone iodine

one local application of 10% povidone iodine ointment

Intervention Type DRUG

Other Intervention Names

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polydine ointment

Eligibility Criteria

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Inclusion Criteria

* skin burns in children

Exclusion Criteria

* allergy to iodine
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sherute Briut Clalit ( HMO)

Principal Investigators

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Arieh Bahir, MD

Role: PRINCIPAL_INVESTIGATOR

Sherute Briut Clalit

Locations

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Sherute Briut Clalit

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

Site Status

Countries

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Israel

Central Contacts

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Arieh Bahir, MD

Role: CONTACT

0544-522877

Other Identifiers

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060/2011K

Identifier Type: -

Identifier Source: org_study_id

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