BurnsPhase 4NCT00156988
The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
A Phase 4 study testing cerium nitrate-silver sulfadiazine (cerium-flamazine) in people with Burns, run by Association of Dutch Burn Centres at 1 site in Netherlands.
Trial summary
The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- cerium nitrate-silver sulfadiazine (cerium-flamazine)
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Mar 2004to Dec 2005
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients having partial thickness burns with TBSA of < 10%
Who cannot join
- patients not seen within 24 hours postburn
- patients with only facial burns
- patients with electrical or chemical burns
- patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
Read the detailed description
Cerium is suggested to halt the cytokine cascade ensuing burn injury by binding the 'burn toxin' and, when used in combination with silver-sulfadiazine, may enhance its antibacterial effect. Since 1984, the combination of cerium and silver sulfadiazine, flammacerium, has been used in our centre. Current practice is to treat acute, non-facial, burns with daily cleaning and (re-)application of flammacerium for a total of ten days. However, prolonged application of cerium is thought to be unnecessary - it is effective in the early stages after injury- and prolonged application of silver sulfadiazine has a negative effect on wound healing. The objective of the proposed study is therefore, to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
- Conditions
- Burns
- Being tested
- cerium nitrate-silver sulfadiazine (cerium-flamazine)
- Keywords
- burns, partial thickness, cerium flamazine, randomised clinical trial
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerium nitrate-silver sulfadiazine (cerium-flamazine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed
Secondary outcomes (1)
Wound colonisation, assessed by swabs taken at 0 or 3 days pb, 7 days pb and subsequently every 7 days until wounds are healed or treated surgically, and on indication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Burns Foundation
- Investigators
- Marianne K Nieuwenhuis, PhD, Principal investigator, Association Dutch Burns Centres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156988
- Sponsor's protocol ID
- WO/P04.103
- Other IDs
- WO/P04.103
- Status last verified
- Aug 2009
- First submitted
- 8 Sep 2005
- Last updated
- 10 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
- ClinicalTrials.gov ID
- NCT00156988
- Acronym / sponsor ID
- WO/P04.103
- Conditions
- Burns
- Keywords
- burns, partial thickness, cerium flamazine, randomised clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Collaborators
- Dutch Burns Foundation
- Study start
- Mar 2004
- Study completion
- Dec 2005
- First posted
- 12 Sep 2005 (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 objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
Detailed description
Cerium is suggested to halt the cytokine cascade ensuing burn injury by binding the 'burn toxin' and, when used in combination with silver-sulfadiazine, may enhance its antibacterial effect. Since 1984, the combination of cerium and silver sulfadiazine, flammacerium, has been used in our centre. Current practice is to treat acute, non-facial, burns with daily cleaning and (re-)application of flammacerium for a total of ten days. However, prolonged application of cerium is thought to be unnecessary - it is effective in the early stages after injury- and prolonged application of silver sulfadiazine has a negative effect on wound healing. The objective of the proposed study is therefore, to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients having partial thickness burns with TBSA of < 10%
Key exclusion criteria (4 listed)
- patients not seen within 24 hours postburn
- patients with only facial burns
- patients with electrical or chemical burns
- patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent
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 |
|---|---|---|
| cerium nitrate-silver sulfadiazine (cerium-flamazine) | Drug | – |
Primary outcome
number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed
1 secondary outcome
Wound colonisation, assessed by swabs taken at 0 or 3 days pb, 7 days pb and subsequently every 7 days until wounds are healed or treated surgically, and on indication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
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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.
Marianne K Nieuwenhuis, PhD principal investigator
Association Dutch Burns Centres
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cerium nitrate-silver sulfadiazine (cerium-flamazine) in people with Burns, run by Association of Dutch Burn Centres at 1 site in Netherlands.
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 4 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: finished, as of the sponsor's last update on 10 Aug 2009. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed. 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 Aug 2009.