PainNCT01289340
Wound Healing and Pain Management in Partial Thickness Burns
An observational study of Pain, run by Rabin Medical Center at 1 site in Israel.
Trial summary
the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pain
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Mar 2017
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients ages 18-40 with no co-morbidities nor pregnant.
Who may be able to join
- patients with minor superficial partial thickness burns
Who cannot join
- co-morbidities, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Management and Wound Healing in Partial Thickness Burn: Comparative, Post Marketing, Observational Trail Comparing Advanced Foam Dressings to Conventional Treatment.
the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns
- Conditions
- Pain
- Keywords
- wound healing, pain, burn
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Polymem (R) | superficial burns treated with Polymem wound dressing until complete wound healing | |
| Biaten IBU | burns treated with Biaten IBU until complete wound healing. | |
| Hartmen dressing | burns treated with hartman or saline wet dressing until wound healing |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete wound healing
final burn wound closure
Measured: up to two to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startOct 2015 (estimated)
- Primary completionOct 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dean david ed-el, Rabin Medical Center
- Investigators
- Dean D Ad El, MD, Principal investigator, Rabin medcial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289340
- Sponsor's protocol ID
- 6021rmc
- Status last verified
- Oct 2020
- First submitted
- 2 Feb 2011
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management and Wound Healing in Partial Thickness Burn: Comparative, Post Marketing, Observational Trail Comparing Advanced Foam Dressings to Conventional Treatment.
- ClinicalTrials.gov ID
- NCT01289340
- Acronym / sponsor ID
- 6021rmc
- Conditions
- Pain
- Keywords
- wound healing, pain, burn
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Oct 2015 (estimated)
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 Feb 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.
the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary ER treatment of superficial partial thickness burns
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polymem (R) | – | –superficial burns treated with Polymem wound dressing until complete wound healing |
| Biaten IBU | – | –burns treated with Biaten IBU until complete wound healing. |
| Hartmen dressing | – | –burns treated with hartman or saline wet dressing until wound healing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients ages 18-40 with no co-morbidities nor pregnant.
Key inclusion criteria (1 listed)
- patients with minor superficial partial thickness burns
Key exclusion criteria (1 listed)
- co-morbidities, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
complete wound healing
Time frame: up to two to three weeks
final burn wound closure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
Dean D Ad El, MD principal investigator
Rabin medcial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Rabin 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: withdrawn, as of the sponsor's last update on 8 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete wound healing (time frame: up to two to three weeks). 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 8 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.