ceriumnitrate silversulfadiazine (flammacerium)
Drugtreatment of patients with facial burns with CE-SSD
Other names: CE-SSD
NCT Number: NCT00297752
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Red Cross Hopsital, Burns Centre, Beverwijk, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
treatment of patients with facial burns with CE-SSD
Other names: CE-SSD
treatment of patients with facial burns with SSD
Other names: SSD
Time frame: 3 weeks
time to wound healing
Time frame: 6 weeks
number of patients requiring surgical treatment for healing of facial burns
Time frame: 3 months
discrepancy between patient and observer scar assessment
Time frame: 6 months post burn
measurement of self esteem related to scar quality
Time frame: 12 months post burn
scar assessment by patient and observer scar scale
Time frame: 12 months post burn
scar assessment by cutometer and dermaspectrometer
Time frame: 12 months post burn
scar thickness area
Time frame: 12 months post burn
descriptive analysis
Time frame: 12 months post burn
physical examination
Association of Dutch Burn Centres
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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