The Counter-irritating Efficacy of Topical Povidone-iodin... | NCT01350713

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

NCT01350713

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

May 10, 2011Estimated

Enrollment

280Estimated

Phase

Not Applicable

Conditions

Skin Burns

Interventions

povidone iodine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

May 8, 2011

First Submission Date that Met QC Criteria

May 9, 2011

First Posted Date

May 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2011

Last Update Posted Date

May 10, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Meir Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

280Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
povidone iodine	Experimental		Drug: povidone iodine
cold water	Active Comparator	treatment by cold water after burn	Drug: povidone iodine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
povidone iodine	Drug	one local application of 10% povidone iodine ointment	cold water povidone iodine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

skin burns in children

Exclusion Criteria:

allergy to iodine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arieh Bahir, MD	Contact	0544-522877		abahir@clalit.org.il

Overall Officials

Name	Affiliation	Role
Arieh Bahir, MD	Sherute Briut Clalit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherute Briut Clalit		Tel Aviv Region	Gush Dan, Heifa, Beer Sheva	59501	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010292	Paresthesia
D002056	Burns

Ancestor Terms

ID	Term
D020886	Somatosensory Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011206	Povidone-Iodine

Ancestor Terms

ID	Term
D007466	Iodophors
D017613	Iodine Compounds
D007287	Inorganic Chemicals
D011145	Polyvinyls

Browse Leaves

Not provided

Browse Branches

Not provided