Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing
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|ClinicalTrials.gov Identifier: NCT00297752|
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : August 10, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Burns||Drug: ceriumnitrate silversulfadiazine (flammacerium) Drug: silversulfadiazine (flammazine)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2006|
|Actual Study Completion Date :||December 2008|
- Regarding the efficacy of treatment
- * number of patients requiring surgical excision of their facial burns
- Regarding psychosocial impact:
- * quality of life and self esteem
- ● quality of scar (patient and observer)
- ● scar elasticity, vascularisation and pigmentation,
- ● hypertrophic surface area
- ● functional and/or anatomic impairments,
- ● mimic function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297752
|Red Cross Hopsital, Burns Centre|
|Beverwijk, Netherlands, 1942 LE|
|Martini Hospital, Burns centre|
|Groningen, Netherlands, 9728 NZ|
|Medical Centre Rijnmond South, Burns centre|
|Rotterdam, Netherlands, 3075 EA|
|Principal Investigator:||Nancy van Loey, PhD||Association of Dutch Burns Centres|
|Principal Investigator:||Marianne K Nieuwenhuis, PhD||Association of Dutch Burn Centres|