BurnsPhase 4NCT00297752
Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
A Phase 4 study testing ceriumnitrate silversulfadiazine (flammacerium) and silversulfadiazine (flammazine) in people with Burns, run by Association of Dutch Burn Centres at 3 sites in Netherlands.
Trial summary
The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- ceriumnitrate silversulfadiazine (flammacerium) and silversulfadiazine (flammazine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesNetherlands
- Study dates
- Mar 2006to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face
Who cannot join
- patients not seen within 24 hours postburn
- patients with mental or cognitive deficits that may interfere with providing informed consent
- patients with poor Dutch proficiency
- patients with chemical burns
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Red Cross Hopsital, Burns Centre
Beverwijk, 1942 LE
Martini Hospital, Burns centre
Groningen, 9728 NZ
Medical Centre Rijnmond South, Burns centre
Rotterdam, 3075 EA
About this study
Official title: A Randomised Multicentre Clinical Trial on the Efficacy of Flammacerium in the Treatment of Facial Burns and the Impact of Facial Burns on Psychosocial Wellbeing
The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing.
In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome.
Read more
Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support.
By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.
- Conditions
- Burns
- Being tested
- ceriumnitrate silversulfadiazine (flammacerium), silversulfadiazine (flammazine)
- Keywords
- facial burns, cerium flammazine, quality of life, 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.
ceriumnitrate silversulfadiazine (flammacerium)Drug
Also called CE-SSD
treatment of patients with facial burns with CE-SSD
silversulfadiazine (flammazine)Drug
Also called SSD
treatment of patients with facial burns with SSD
| Study group | Role | What they receive |
|---|---|---|
| 'ceriumnitrate silversulfadiazine (flammacerium) | Active comparator | facial burns treatment with Cerium nitrate silver sulfadiazine Receives: Drug: ceriumnitrate silversulfadiazine (flammacerium) |
| flammazine | Active comparator | facial burns treatment with silver sulfadiazine Receives: Drug: silversulfadiazine (flammazine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regarding the efficacy of treatment
time to wound healing
Measured: 3 weeks
* number of patients requiring surgical excision of their facial burns
number of patients requiring surgical treatment for healing of facial burns
Measured: 6 weeks
Regarding psychosocial impact:
discrepancy between patient and observer scar assessment
Measured: 3 months
* quality of life and self esteem
measurement of self esteem related to scar quality
Measured: 6 months post burn
Secondary outcomes (5)
● quality of scar (patient and observer)
scar assessment by patient and observer scar scale
Measured: 12 months post burn
● scar elasticity, vascularisation and pigmentation,
scar assessment by cutometer and dermaspectrometer
Measured: 12 months post burn
● hypertrophic surface area
scar thickness area
Measured: 12 months post burn
● functional and/or anatomic impairments,
descriptive analysis
Measured: 12 months post burn
● mimic function
physical examination
Measured: 12 months post burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startMar 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Burns Foundation
- Responsible party
- Sponsor
- Investigators
- Nancy van Loey, PhD, Principal investigator, Association of Dutch Burns CentresMarianne K Nieuwenhuis, PhD, Principal investigator, Association of Dutch Burn Centres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297752
- Sponsor's protocol ID
- WO/PO.109
- Status last verified
- Aug 2009
- First submitted
- 28 Feb 2006
- Last updated
- 17 Feb 2020
- Results posted
- No
Publications
Oen IMMH, van Baar ME, Middelkoop E, Nieuwenhuis MK. Effectiveness of cerium nitrate-silver sulfadiazine in the treatment of facial burns: a multicenter, randomized, controlled trial. Plast Reconstr Surg. 2012 Aug;130(2):274e-283e. doi: 10.1097/PRS.0b013e3182589d63.
PubMed 22842424
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Multicentre Clinical Trial on the Efficacy of Flammacerium in the Treatment of Facial Burns and the Impact of Facial Burns on Psychosocial Wellbeing
- ClinicalTrials.gov ID
- NCT00297752
- Acronym / sponsor ID
- WO/PO.109
- Conditions
- Burns
- Keywords
- facial burns, cerium flammazine, quality of life, randomised clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Collaborators
- Dutch Burns Foundation
- Study start
- Mar 2006
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Mar 2006 (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 face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing.
In clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome.
Apart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support.
By evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'ceriumnitrate silversulfadiazine (flammacerium) | Active comparator | Drug: ceriumnitrate silversulfadiazine (flammacerium)facial burns treatment with Cerium nitrate silver sulfadiazine |
| flammazine | Active comparator | Drug: silversulfadiazine (flammazine)facial burns treatment with silver sulfadiazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face
Key exclusion criteria (4 listed)
- patients not seen within 24 hours postburn
- patients with mental or cognitive deficits that may interfere with providing informed consent
- patients with poor Dutch proficiency
- patients with chemical burns
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 |
|---|---|---|
| ceriumnitrate silversulfadiazine (flammacerium)Also: CE-SSDtreatment of patients with facial burns with CE-SSD | Drug | 'ceriumnitrate silversulfadiazine (flammacerium) |
| silversulfadiazine (flammazine)Also: SSDtreatment of patients with facial burns with SSD | Drug | flammazine |
Primary outcome
Regarding the efficacy of treatment
Time frame: 3 weeks
time to wound healing
* number of patients requiring surgical excision of their facial burns
Time frame: 6 weeks
number of patients requiring surgical treatment for healing of facial burns
Regarding psychosocial impact:
Time frame: 3 months
discrepancy between patient and observer scar assessment
* quality of life and self esteem
Time frame: 6 months post burn
measurement of self esteem related to scar quality
5 secondary outcomes
● quality of scar (patient and observer)
Time frame: 12 months post burn
● scar elasticity, vascularisation and pigmentation,
Time frame: 12 months post burn
● hypertrophic surface area
Time frame: 12 months post burn
● functional and/or anatomic impairments,
Time frame: 12 months post burn
● mimic function
Time frame: 12 months post burn
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 17 Feb 2020.
- Derived from this study: PubMed 22842424Oen IMMH, van Baar ME, Middelkoop E, Nieuwenhuis MK. Effectiveness of cerium nitrate-silver sulfadiazine in the treatment of facial burns: a multicenter, randomized, controlled trial. Plast Reconstr Surg. 2012 Aug;130(2):274e-283e. doi: 10.1097/PRS.0b013e3182589d63.
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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.
Nancy van Loey, PhD principal investigator
Association of Dutch Burns Centres
Marianne K Nieuwenhuis, PhD principal investigator
Association of Dutch Burn Centres
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ceriumnitrate silversulfadiazine (flammacerium) and silversulfadiazine (flammazine) in people with Burns, run by Association of Dutch Burn Centres at 3 sites 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Regarding the efficacy of treatment (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297752, which also lists 1 linked publication.
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 17 Feb 2020.