Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
Information source: Association of Dutch Burn Centres
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Burns
Intervention: ceriumnitrate silversulfadiazine (flammacerium) (Drug); silversulfadiazine (flammazine) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Association of Dutch Burn Centres Official(s) and/or principal investigator(s):
Nancy van Loey, PhD, Principal Investigator, Affiliation: Association of Dutch Burns Centres
Marianne K Nieuwenhuis, PhD, Principal Investigator, Affiliation: Association of Dutch Burn Centres
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. 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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Regarding the efficacy of treatment* number of patients requiring surgical excision of their facial burns Regarding psychosocial impact: * quality of life and self esteem
Secondary outcome: ● quality of scar (patient and observer)● scar elasticity, vascularisation and pigmentation, ● hypertrophic surface area ● functional and/or anatomic impairments, ● mimic function
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Martini Hospital, Burns centre, Groningen 9728 NZ, Netherlands; Recruiting
Marianne K Nieuwenhuis, PhD, Phone: +31 (0)50-5245245, Ext: 5565, Email: m.k.nieuwenhuis@mzh.nl
Marianne K Nieuwenhuis, PhD, Principal Investigator
Red Cross Hopsital, Burns Centre, Beverwijk 1942 LE, Netherlands; Recruiting
Antoon J van den Bogaerdt, PhD, Phone: + 31 (0)251-265555, Ext: 4917, Email: avdbogaerdt@burns.nl
Antoon J van den Bogaerdt, PhD, Principal Investigator
Medical Centre Rijnmond South, Burns centre, Rotterdam 3075 EA, Netherlands; Recruiting
Irma M. Oen, M.D., Phone: +31 (0)10 290 30 00, Ext: 3135, Email: oeni@mcrz.nl
Irma M. Oen, M.D., Principal Investigator
Additional Information
Starting date: March 2006
Ending date: August 2008
Last updated: October 22, 2007
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