Skin BurnsNCT01350713
The Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns
A study testing povidone iodine in people with Skin Burns, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Burns
- What is being tested?
- povidone iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- skin burns in children
Who cannot join
- allergy to iodine
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sherute Briut Clalit
Tel Aviv Region, Gush Dan, Heifa, Beer Sheva, 59501
Arieh Bahir, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Burns
- Being tested
- povidone iodine
- Keywords
- skin, burn, povidone iodine, cold water
- Medical subject headings
- Paresthesia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
povidone iodineDrug
Also called polydine ointment
one local application of 10% povidone iodine ointment
| Study group | Role | What they receive |
|---|---|---|
| povidone iodine | Experimental | Not described Receives: Drug: povidone iodine |
| cold water | Active comparator | treatment by cold water after burn Receives: Drug: povidone iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
scar prevention
povidine treated individuals no scar will develop. standard cold water treated patients may develop skin lesions(scars)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Arieh Bahir, MD, Principal investigator, Sherute Briut Clalit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350713
- Sponsor's protocol ID
- 060/2011K
- Status last verified
- May 2011
- First submitted
- 8 May 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Counter-irritating Efficacy of Topical Povidone-iodine in Thermal Burns; Comparison to Conventional Treatments
- ClinicalTrials.gov ID
- NCT01350713
- Acronym / sponsor ID
- 060/2011K
- Conditions
- Skin Burns
- Keywords
- skin, burn, povidone iodine, cold water
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| povidone iodine | Experimental | Drug: povidone iodine |
| cold water | Active comparator | Drug: povidone iodinetreatment by cold water after burn |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- skin burns in children
Key exclusion criteria (1 listed)
- allergy to iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| povidone iodineAlso: polydine ointmentone local application of 10% povidone iodine ointment | Drug | cold water, povidone iodine |
Primary outcome
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 secondary outcome
scar prevention
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arieh Bahir, MD principal investigator
Sherute Briut Clalit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing povidone iodine in people with Skin Burns, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arieh Bahir, MD (0544-522877, abahir@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of skin lesions caused by exposure to heat source (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.